Nifedipine

Product NDC
0615-8549
11-digit product format
006158549
Labeler code
0615
Product ID
0615-8549_6c94fb65-af22-4bfd-a639-2c9545775c54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I9ZF7L6G2LNIFEDIPINE21829-25-4NIFEDIPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8549-390061585493930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8549-39) 2024-10-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended -release Tablets, USP For Oral UseNCS HealthCare of KY, LLC dba Vangard Labs2024-10-18HUMAN PRESCRIPTION DRUG LABEL1