Nifedipine

Product NDC
71335-1550
11-digit product format
713351550
Labeler code
71335
Product ID
71335-1550_c2fce108-407e-4e6a-a003-654fad42839b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011

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
71335-1550-1Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-1550-2Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
71335-1550-3Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-1550-4Nifedipine60 in 1 BOTTLETABLET, EXTENDED RELEASE605
71335-1550-5Nifedipine7 in 1 BOTTLETABLET, EXTENDED RELEASE75
71335-1550-6Nifedipine10 in 1 BOTTLETABLET, EXTENDED RELEASE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1550NIFEDIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20250330_325acf27-4b2e-40e8-8344-bb6cc9959910.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN325acf27-4b2e-40e8-8344-bb6cc99599105
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD325acf27-4b2e-40e8-8344-bb6cc99599105
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY325acf27-4b2e-40e8-8344-bb6cc99599105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1550-17133515500130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-1) 2020-12-040000-00-00NoNoCurrent
71335-1550-271335155002100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-2) 2022-10-130000-00-00NoNoCurrent
71335-1550-37133515500390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-3) 2020-03-250000-00-00NoNoCurrent
71335-1550-47133515500460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-4) 2020-08-060000-00-00NoNoCurrent
71335-1550-5713351550057 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-5) 2022-10-130000-00-00NoNoCurrent
71335-1550-67133515500610 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-6) 2022-10-13NoNoCurrent