FDA.reportPublic FDA data

Nifedipine

Product NDC
71335-2132
11-digit product format
713352132
Labeler code
71335
Product ID
71335-2132_5cb5ba49-d959-4e98-8c12-efff26869287
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
90 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
NIFEDIPINE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812015

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
71335-2132-1Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE30102
71335-2132-2Nifedipine60 in 1 BOTTLETABLET, EXTENDED RELEASE60102
71335-2132-3Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE90102
71335-2132-4Nifedipine180 in 1 BOTTLETABLET, EXTENDED RELEASE180102
71335-2132-5Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2132NIFEDIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20230603_71a4e00b-8386-4da1-8515-a0e7e8db104d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY71a4e00b-8386-4da1-8515-a0e7e8db104d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2132-17133521320130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-1) 2022-07-270000-00-00NoNoCurrent
71335-2132-27133521320260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-2) 2022-07-270000-00-00NoNoCurrent
71335-2132-37133521320390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-3) 2022-07-270000-00-00NoNoCurrent
71335-2132-471335213204180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-4) 2022-07-270000-00-00NoNoCurrent
71335-2132-571335213205100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-5) 2022-07-270000-00-00NoNoCurrent