Nifedipine how supplied storage and handling

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Nifedipine
NIFEDIPINE® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Nifedipine
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: : Abdurahman Khalil, M.D. [2]

For patient information about Nifedipine, click here.

HOW SUPPLIED(NIFEDIPINE CAPSULES)

Nifedipine Capsules, USP are available as white opaque, oblong soft gelatin capsules containing 10 mg of nifedipine. Each capsule is imprinted with "HP 194" in black ink. They are supplied as follows:

Bottles of 100: 10 mg (NDC 23155-194-01) Bottles of 300: 10 mg (NDC 23155-194-13)

Nifedipine Capsules, USP are available as peach opaque, oblong soft gelatin capsules containing 20 mg of nifedipine. Each capsule is imprinted with "HP 195" in black ink. They are supplied as follows:

Bottles of 100: 20 mg (NDC 23155-195-01)

The capsules should be protected from light and moisture and stored at controlled room temperature 68° to 77°F (20° to 25°C); excursions permitted to 15° to 30°C (59° to 86°F), in the manufacturer's original container.

Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) MF# 0331-02

Rev. 09/13

HOW SUPPLIED (NIFEDIPINE EXTENDED RELEASE

Nifedipine Extended-release Tablets are supplied as 30 mg, 60 mg and 90 mg round, biconvex, rose-pink, film-coated tablets.

The 30 mg tablet is imprinted with M over 475 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-940-20

     Unit dose packages of 100 tablets

The 60 mg tablet is imprinted with M over 482 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-968-20

     Unit dose packages of 100 tablets

The 90 mg tablet is imprinted with M over 495 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-969-20

     Unit dose packages of 100 tablets

STORE BELOW 86°F (30°C).

PROTECT FROM MOISTURE AND HUMIDITY.

Dispense in tight, child-resistant containers (USP).

Distributed by:

UDL Laboratories, Inc. Rockford, IL 61103

Manufactured by:

Pfizer Pharmaceuticals LLC Barceloneta, PR 00617

LAB-0177-3.0

References

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=03be089c-07e5-4f94-bfcc-c6101b311785