FDA.reportPublic FDA data

Nifedipine

Product NDC
67046-0260
11-digit product format
670460260
Labeler code
67046
Product ID
67046-0260_518d2e7b-cc51-ba63-e063-6294a90af691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA210614
Marketing category
ANDA
Marketing start
2026-05-11
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
2027-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-0260-3Nifedipine30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN518d39af-0be1-acbc-e063-6294a90a4ada1
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD518d39af-0be1-acbc-e063-6294a90a4ada1
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY518d39af-0be1-acbc-e063-6294a90a4ada1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-0260-36704602600330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-0260-3) 2026-05-11NoNoHistorical