Nifedipine

Product NDC
43353-929
11-digit product format
433530929
Labeler code
43353
Product ID
43353-929_4413cc8b-fe40-438e-9c33-46e699dab2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201071
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-929-09Nifedipine9000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE90001
43353-929-30Nifedipine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301
43353-929-60Nifedipine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-929NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20171219_093a8712-c860-4524-86f6-a9edcd35b882.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN093a8712-c860-4524-86f6-a9edcd35b8821
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD093a8712-c860-4524-86f6-a9edcd35b8821
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY093a8712-c860-4524-86f6-a9edcd35b8821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-929-09433530929099000 in 1 BOTTLE, PLASTICHistorical
43353-929-304335309293030 in 1 BOTTLE, PLASTICHistorical
43353-929-604335309296090 in 1 BOTTLE, PLASTICHistorical