Nifedipine (Page 5 of 5)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets, USP be administered orally once daily on an empty stomach. The nifedipine extended-release tablet, USP is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.

If discontinuation of the nifedipine extended-release tablet is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Co-administration of nifedipine with grapefruit juice is to be avoided (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended release dosage form has been prescribed.

HOW SUPPLIED

Nifedipine extended-release tablets, USP are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:

NDC 68071-4411-3 BOTTLES OF 30

NDC 68071-4411-6 BOTTLES OF 60

NDC 68071-4411-9 BOTTLES OF 90

The tablets should be protected from light and moisture and stored at 20°-25°C (68°-77°F); [See USP Controlled Room

Temperature].

Dispense in tight, light-resistant containers.

image6

SPL UNCLASSIFIED

Manufactured for:

Ingenus Pharmaceuticals, LLC

Orlando, FL 32839-6408

Customer toll-free number: 1-877-748-1970

Manufactured by:

Novast Laboratories Ltd.

Nantong, China 226009

Rx Only

I0086

Iss. 01/2017

Rev. A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIFEDIPINE nifedipine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4411(NDC:50742-621) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 60 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE TALC POLYETHYLENE GLYCOL 3350 LECITHIN, SOYBEAN FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE

Product Characteristics Color pink Score no score Shape ROUND Size 9mm Flavor Imprint Code Novast;36 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-4411-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68071-4411-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68071-4411-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202987 02/15/2017

Labeler — NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals,Inc.		010632300	repack (68071-4411)

Revised: 02/2022 NuCare Pharmaceuticals,Inc.