Novolin 70/30

Name: Novolin 70/30

What is the most important information I should know about Novolin 70/30 (insulin isophane and insulin regular)?

Never share an injection pen or syringe with another person, even if the needle has been changed.

What should I discuss with my healthcare provider before using Novolin 70/30 (insulin isophane and insulin regular)?

You should not use this medicine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin isophane and insulin regular is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver or kidney disease; or

  • low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

What happens if I miss a dose?

Since this medicine is used with a meal, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 45 minutes. Do not use extra medicine to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Principal Display Panel - InnoLet

Novolin® 70/30 InnoLet®3 mL

70% NPH, Human Insulin Isophane Suspension and

30% Regular, Human Insulin Injection

(recombinant DNA origin)

NDC 0169-2317-21

List 231721

100 units/mL (U-100)

5x3 mL InnoLet Prefilled Syringes

Keep in cold place between 36° - 46°F (2° - 8°C)

Avoid freezing

NOVOLIN  70/30
human insulin injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-1837
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN (INSULIN HUMAN) INSULIN HUMAN 100 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
METACRESOL  
PHENOL  
PROTAMINE SULFATE  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE  
ZINC CHLORIDE  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:0169-1837-11 1 VIAL (VIAL) in 1 CARTON
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019991 06/25/1991
NOVOLIN  70/30
human insulin injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-3477
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN (INSULIN HUMAN) INSULIN HUMAN 100 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
METACRESOL  
PHENOL  
PROTAMINE SULFATE  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
WATER  
ZINC CHLORIDE  
Packaging
# Item Code Package Description
1 NDC:0169-3477-18 5 CARTRIDGE (CARTRIDGE) in 1 CARTON
1 3 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019991 06/25/1991 07/31/2011
NOVOLIN  70/30
human insulin injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-2317
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN (INSULIN HUMAN) INSULIN HUMAN 100 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ZINC CHLORIDE  
GLYCERIN  
METACRESOL  
PHENOL  
PROTAMINE SULFATE  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:0169-2317-21 5 SYRINGE, GLASS (SYRINGE) in 1 CARTON
1 3 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019991 12/10/2001 01/31/2012
Labeler - Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk Pharmaceuticals Industries Inc. 622920320 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 312296002 MANUFACTURE
Revised: 10/2010   Novo Nordisk
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