Nifedipine

Product NDC: 71205-412
11-digit product format: 712050412
Labeler code: 71205
Product ID: 71205-412_838d6e8f-37b0-48d3-b701-c4fa32a87b85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA203126
Marketing category: ANDA
Marketing start: 2014-11-01
Substance: NIFEDIPINE
Active strength: 60 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: 71205-412_838d6e8f-37b0-48d3-b701-c4fa32a87b85
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Nifedipine
Generic name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing start: 2014-11-01
Marketing category: ANDA
Application number: ANDA203126
Pharmacologic classes: Calcium Channel Antagonists [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
NIFEDIPINE	60 mg/1

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

Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-412-30	71205041230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-30)	2020-02-26	0000-00-00	No	No	Current
71205-412-60	71205041260	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-60)	2020-02-26	0000-00-00	No	No	Current
71205-412-90	71205041290	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-90)	2020-02-26	0000-00-00	No	No	Current

Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-release Tablets, USP	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	1