nifedipine

Product NDC
71335-0744
11-digit product format
713350744
Labeler code
71335
Product ID
71335-0744_371d22d6-5644-4756-9bce-03fe3f104db0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075289
Marketing category
ANDA
Marketing start
2000-09-27
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

Additional Listing Data#

Finished product
Yes
Brand name base
nifedipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE60 mg/1

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
71335-0744-1nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
71335-0744-2nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903
71335-0744-3nifedipine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
71335-0744-4nifedipine28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0744NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 4 package rows20200121_d7475c68-6310-4b9a-81c1-9209a9ade75f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNd7475c68-6310-4b9a-81c1-9209a9ade75f3
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDd7475c68-6310-4b9a-81c1-9209a9ade75f3
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYd7475c68-6310-4b9a-81c1-9209a9ade75f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0744-17133507440130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0744-1) 2018-03-210000-00-00NoNoCurrent
71335-0744-27133507440290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0744-2) 2018-03-210000-00-00NoNoCurrent
71335-0744-37133507440360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0744-3) 2018-03-210000-00-00NoNoCurrent
71335-0744-47133507440428 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0744-4) 2018-03-210000-00-00NoNoCurrent