Nifedipine

Product NDC
43353-209
11-digit product format
433530209
Labeler code
43353
Product ID
43353-209_9e0cad11-64f5-41e1-986d-d696d8a6e7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075269
Marketing category
ANDA
Marketing start
2000-12-04
Marketing end
0000-00-00
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-209-302020-01-31C16284748780-19d75b9d1-103e-f424-e053-dadaa90a57ceNifedipine Extended-Release Tablets, USP 60 mg
43353-209-602020-01-31C16284748780-19d75b9d1-103e-f424-e053-dadaa90a57ceNifedipine Extended-Release Tablets, USP 60 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-209-30Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE301
43353-209-60Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-209NIFEDIPINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20171012_61eff839-7c98-4d49-bfb2-cb67b5dc5f6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-209-304335302093030 in 1 BOTTLEHistorical
43353-209-604335302096090 in 1 BOTTLEHistorical