Nifedipine

Product NDC
55289-798
11-digit product format
552890798
Labeler code
55289
Product ID
55289-798_419b65f7-5d45-aff4-e063-6294a90a2a36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077127
Marketing category
ANDA
Marketing start
2005-11-21
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I9ZF7L6G2LNIFEDIPINE21829-25-4NIFEDIPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55289-798-07552890798077 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-07) 2011-10-21NoNoHistorical
55289-798-305528907983030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-30) 2011-10-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended-release Tablets, USPPD-Rx Pharmaceuticals, Inc.2025-10-20HUMAN PRESCRIPTION DRUG LABEL31
Nifedipine Extended-release Tablets, USPPD-Rx Pharmaceuticals, Inc.2024-03-12HUMAN PRESCRIPTION DRUG LABEL30