Tirosint

Name: Tirosint

  • Tirosint-Sol

© Tirosint Patient Information is supplied by Cerner Multum, Inc. and Tirosint Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What do I need to tell my doctor BEFORE I take Tirosint?

  • If you have an allergy to levothyroxine or any other part of Tirosint.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Overactive thyroid gland, recent heart attack, or weak adrenal gland.
  • If you have trouble swallowing.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Tirosint with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tirosint?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine sodium.

Patient Counseling Information

Advise the patient and/or the caregiver to read the FDA-approved patient labeling (Patient Information Sheet).

Dosing and Administration

  • Instruct patients to take Tirosint only as directed by their healthcare provider.
  • Instruct patients to take Tirosint one-half to one hour before breakfast.
  • Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take Tirosint within 4 hours of these agents.
  • Instruct patients that Tirosint capsules should be swallowed whole and never be crushed or cut.
  • To assist with identifying the name and strength of each Tirosint capsule, instruct patients not to remove capsules from the blisters in advance, particularly if they are taking multiple strengths.
  • Instruct patients to notify their healthcare provider should they become pregnant or are thinking of becoming pregnant while taking Tirosint.

Important Information

  • Inform patients that it may take several weeks before they notice an improvement in symptoms.
  • Inform patients that the levothyroxine in Tirosint is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
  • Inform patients that Tirosint should not be used as a primary or adjunctive therapy in a weight control program.
  • Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations [see Drug Interactions (7)].
  • Instruct patients to notify their healthcare provider of any other medical conditions, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while taking Tirosint. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.
  • Instruct patients to notify their physician or dentist that they are taking Tirosint prior to any surgery.

Adverse Reactions

  • Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.
  • Inform patients that partial hair loss may occur rarely during the first few months of Tirosint therapy, but this is usually temporary.

Manufactured for Akrimax Pharmaceuticals, LLC by:

IBSA Institut Biochimique SA
6915 Pambio-Noranco
Switzerland

Distributed by:

Akrimax Pharmaceuticals, LLC,
Cranford, NJ07016
USA

Version April 2017
FI/164 9004
Ed. V/04.17
1047F004 Rev 04/17

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: April 2017
PATIENT INFORMATION
Tirosint® [tee-row-sent]
(levothyroxine sodium)
capsules, for oral use
What is the most important information I should know about Tirosint?
  • Do not use Tirosint to treat weight problems or weight loss.
  • Do not take more Tirosint than your doctor prescribes for you to take. Over dosage or taking too much Tirosint may cause life-threatening side effects or death.
What is Tirosint?

Tirosint is a prescription medicine that contains a hormone called levothyroxine which is normally produced by the thyroid gland. Tirosint is used to treat adults and children 6 years of age or older:

  • to replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone.
  • who need surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.

Tirosint should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.

Tirosint is unsuitable for children less than 6 years of age or who may be unable to swallow an intact capsule.

Do not take Tirosint:
  • if your adrenal glands are not working well and you have not been treated for this problem.
Before you take Tirosint, tell your doctor about all of your medical conditions, including if you:
  • have or had heart problems.
  • have or had thyroid nodules.
  • have kidney or pituitary gland problems.
  • have any food or drug allergies.
  • have a low red blood cell count (anemia).
  • have diabetes.
  • have weak bones (osteoporosis).
  • have or had a history of blood clotting problems.
  • have recently received radiation therapy with iodine (such as I-131).
  • are pregnant or plan to become pregnant. Tirosint may harm your unborn baby. Your doctor may need to change your Tirosint dose while you are pregnant.
  • are breastfeeding. Tirosint can pass into your milk. Talk to your doctor about the best way to feed your baby if you take Tirosint.

Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tirosint may affect the way other medicines work, and other medicines may affect how Tirosint works. You can ask your doctor or pharmacist for a list of medicines that interact with Tirosint.

How should I take Tirosint?
  • Take Tirosint exactly as your doctor tells you to take it.
  • Your doctor will tell you how much Tirosint to take each day.
  • Swallow Tirosint capsules whole. Do not break, crush, or chew Tirosint capsules before swallowing. If you or your child cannot swallow Tirosint capsules whole, tell your doctor. You may need a different medicine.
  • Your doctor may change your dose, if needed.
  • Take your dose of Tirosint 1 time each day, 30 minutes to 1 hour before breakfast, on an empty stomach.
  • Certain medicines can interfere with how Tirosint is absorbed by your body. Take Tirosint:
    • at least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate).
    • at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins.
  • Know the medicines that you take. Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
  • Certain foods including soybean flour, cotton seed meal, walnuts, and dietary fiber can affect your treatment and dose of Tirosint. Talk to your doctor if you eat or drink these foods.
  • Do not remove Tirosint capsules from the original blister package until you are ready to take them.
  • Your doctor should do certain blood tests while you are taking Tirosint and may change your daily dose of Tirosint as needed. You should not stop taking Tirosint or change your dose unless your doctor tells you to.
  • It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well.
  • If you take too much Tirosint or overdose, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What are the possible side effects of Tirosint?

Tirosint may cause serious side effects, including:

  • heart problems. You may experience an increased heart rate, chest pain and irregular heartbeat. Your risk of developing heart problems may be greater if you are elderly, have heart problems, or if you take too much Tirosint. Your doctor may reduce your dose or stop treatment with Tirosint for a while if you develop heart problems.
  • worsening diabetic control. If you are diabetic, it may be harder to control your blood sugar levels causing hyperglycemia while taking Tirosint. Check your blood sugar levels closely after starting, changing, or stopping treatment with Tirosint. Your doctor may have to change your diabetes treatment plan.
  • weak or brittle bones. Your risk of developing weak or brittle bones may be greater if you are post-menopausal or you take too much Tirosint.

The most common side effects of Tirosint include:

  • irregular heartbeat
  • chest pain
  • shortness of breath
  • leg cramps
  • headache
  • nervousness
  • hives or skin rash
  • irritability
  • sleep problems (insomnia)
  • tremors
  • muscle weakness
  • change in appetite
  • weight loss
  • vomiting
  • diarrhea
  • sweating a lot
  • heat intolerance
  • fever
  • changes in menstrual period
Other side effects may include:
  • partial hair loss during the first months of treatment with Tirosint. This usually lasts a short period of time (temporary).

These are not all the possible side effects of Tirosint. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Akrimax Pharmaceuticals at 1-888-383-1733 or www.fda.gov/medwatch.

How should I store Tirosint?
  • Store Tirosint at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store Tirosint away from heat, light, and moisture.
  • Keep Tirosint in the original blister pack until you are ready to use it.

Keep Tirosint and all medicines out of the reach of children.

General information about the safe and effective use of Tirosint

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tirosint for a condition for which it was not prescribed. Do not give Tirosint to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Tirosint that is written for health professionals.

What are the ingredients in Tirosint?

Active ingredient: levothyroxine sodium

Inactive ingredients: gelatin, glycerin, and water

Manufactured by: Institut Biochimique SA (IBSA). 6915 Pambio-Noranco Switzerland; Marketed and distributed by: Akrimax Pharmaceuticals, LLC, Cranford, NJ 07016 USA For more information, go to www.Tirosint.com or call 1-888-383-1733.

PRINCIPAL DISPLAY PANEL - 100 mcg Capsule Blister Pack Carton

Tirosint®
(levothyroxine sodium) capsules

NDC 24090-495-84

100 mcg
per capsule

Rx Only

Do not remove individual capsules from blister packaging until ready to use

AKRIMAX
PHARMACEUTICALS

4 blisters x 7 capsules

PRINCIPAL DISPLAY PANEL - 112 mcg Capsule Blister Pack Carton

Tirosint®
(levothyroxine sodium) capsules

NDC 24090-496-84

112 mcg
per capsule

Rx Only

Do not remove individual capsules from blister packaging until ready to use

AKRIMAX
PHARMACEUTICALS

4 blisters x 7 capsules

PRINCIPAL DISPLAY PANEL - 200 mcg Capsule Blister Pack Carton

Tirosint®
(levothyroxine sodium) capsules

NDC 24090-501-84

200 mcg
per capsule

Rx Only

Do not remove individual capsules from blister packaging until ready to use

AKRIMAX
PHARMACEUTICALS

4 blisters x 7 capsules

Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-490
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 13 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code A
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-490-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-490-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-490-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-490-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022121 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-491
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 25 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code E
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-491-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-491-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-491-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-491-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-492
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 50 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code G
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-492-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-492-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-492-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-492-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-493
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 75 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code H
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-493-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-493-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-493-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-493-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-494
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 88 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code J
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-494-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-494-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-494-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-494-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-495
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 100 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code K
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-495-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-495-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-495-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-495-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-496
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 112 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code M
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-496-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-496-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-496-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-496-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-497
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 125 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code N
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-497-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-497-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-497-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-497-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-498
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 137 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code P
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-498-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-498-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-498-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-498-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-499
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 150 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code S
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-499-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-499-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-499-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-499-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-500
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 175 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code U
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-500-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-500-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-500-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-500-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Tirosint 
levothyroxine sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24090-501
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levothyroxine Sodium (Levothyroxine) Levothyroxine Sodium Anhydrous 200 ug
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified  
Glycerin  
Water  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 7mm
Flavor Imprint Code Y
Contains     
Packaging
# Item Code Package Description
1 NDC:24090-501-84 4 BLISTER PACK in 1 CARTON
1 7 CAPSULE in 1 BLISTER PACK
2 NDC:24090-501-07 1 BLISTER PACK in 1 CARTON
2 7 CAPSULE in 1 BLISTER PACK
3 NDC:24090-501-94 2 BLISTER PACK in 1 CARTON
3 7 CAPSULE in 1 BLISTER PACK
4 NDC:24090-501-99 4 BLISTER PACK in 1 CARTON
4 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021924 04/01/2010
Labeler - Akrimax Pharmaceuticals, LLC (804790124)
Registrant - IBSA Pambio Noranco Complex (485251214)
Revised: 04/2017   Akrimax Pharmaceuticals, LLC
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