Nifedipine

Product NDC
68071-2619
11-digit product format
680712619
Labeler code
68071
Product ID
68071-2619_2a0755bc-c7fb-a5df-e063-6294a90ac4a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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
68071-2619-36807126190330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2619-3) 2022-01-18NoNoHistorical
68071-2619-96807126190990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2619-9) 2022-01-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended -release Tablets, USP For Oral UseNuCare Pharmaceuticals,Inc.2024-12-24HUMAN PRESCRIPTION DRUG LABEL2