Nifedipine

Product NDC
63187-875
11-digit product format
631870875
Labeler code
63187
Product ID
63187-875_19b531f9-27f9-42e5-8c1e-7015c256bb22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-875-306318708753030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-30) 2017-07-03NoNoHistorical
63187-875-606318708756060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-60) 2017-07-03NoNoHistorical
63187-875-906318708759090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-90) 2017-07-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended-release Tablets, USPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3