Nifedipine

Product NDC
50090-3034
11-digit product format
500903034
Labeler code
50090
Product ID
50090-3034_5b46d2e6-5d7f-4aa8-9a69-d69002bc4f2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077899
Marketing category
ANDA
Marketing start
2016-03-02
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
2020-12-31
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
50090-3034-0Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
50090-3034-1Nifedipine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1006
50090-3034-2Nifedipine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3034NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 3 package rows20190427_16e58a0a-b79b-46b9-ac14-9b1a0578eeab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN16e58a0a-b79b-46b9-ac14-9b1a0578eeab6
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD16e58a0a-b79b-46b9-ac14-9b1a0578eeab6
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY16e58a0a-b79b-46b9-ac14-9b1a0578eeab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3034-05009030340030 in 1 BOTTLEHistorical
50090-3034-150090303401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3034-1) 2016-03-020000-00-00NoNoCurrent
50090-3034-25009030340290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3034-2) 2016-03-020000-00-00NoNoCurrent