Nifedipine

Product NDC: 72162-2534
11-digit product format: 721622534
Labeler code: 72162
Product ID: 72162-2534_ffbebc10-1593-40e8-8be0-fe301dd733fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213361
Marketing category: ANDA
Marketing start: 2021-07-19
Substance: NIFEDIPINE
Active strength: 30 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72162-2534_ffbebc10-1593-40e8-8be0-fe301dd733fe
SPL ID: ffbebc10-1593-40e8-8be0-fe301dd733fe
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Nifedipine
Generic name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing start: 2021-07-19
Marketing category: ANDA
Application number: ANDA213361
Pharmacologic classes: Calcium Channel Antagonists [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
NIFEDIPINE	30 mg/1

Package NDC	Description	Marketing start	Sample
72162-2534-1	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2534-1)	2025-09-19	No

UNII	Preferred term	Registry number	Matched term
I9ZF7L6G2L	NIFEDIPINE	21829-25-4	NIFEDIPINE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2534-1	72162253401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2534-1)	2025-09-19	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP For Oral Use Rx only	Bryant Ranch Prepack	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	100