Cidofovir Injection

Name: Cidofovir Injection

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Notes

Laboratory and/or medical tests (e.g., eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.To decrease your risk of spreading HIV disease to others, always use an effective barrier method (e.g., latex or polyurethane condoms/dental dams) during sexual activity. Consult your doctor or pharmacist for more details.

Missed dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose of cidofovir, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up. If you miss a dose of the probenecid, tell your doctor or pharmacist immediately. You may have to reschedule your cidofovir dose.

Package label principal display panel-Carton

Cidofovir Injection 375 mg/5 mL (75 mg/mL)

Rx only

NDC 23155-216-31

5 mL Single-use Vial

DILUTE BEFORE USEFOR I.V. INFUSION ONLY.

Not for Intraocular Injection.

Each 5 mL single-use vial contains 375 mg (75 mg/mL) of cidofovir (anhydrous). May contain Hydrochloric Acid NF and/or Sodium Hydroxide NF for pH adjustment.

Usual Doasge: See Package Insert for dosage and full prescribing information.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].

Manufactured by:

Emcure Pharmaceuticals Ltd.,

Hinjwadi, Pune, India.

Manufactured for:

Heritage Pharmaceuticals Inc.

Eatontown, NJ 07724

1.866.901.DRUG (3784)

CIDOFOVIR DIHYDRATE 
cidofovir dihydrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23155-216
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIDOFOVIR (CIDOFOVIR ANHYDROUS) CIDOFOVIR ANHYDROUS 375 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:23155-216-31 5 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202501 08/06/2012
Labeler - Heritage Pharmaceuticals Inc. (780779901)
Registrant - Emcure Pharmaceuticals Ltd. (916921919)
Establishment
Name Address ID/FEI Operations
Emcure Pharmaceuticals Limited 862602830 analysis(23155-216), manufacture(23155-216)
Revised: 07/2015   Heritage Pharmaceuticals Inc.
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