FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-4249
11-digit product format
500904249
Labeler code
50090
Product ID
50090-4249_1f1af3de-099f-43ba-8305-643165323d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202987
Marketing category
ANDA
Marketing start
2017-02-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4249-02023-01-30C16284748780-1f386c649-bf76-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30mg, 60mg and 90mg
50090-4249-12023-01-30C16284748780-1f386c649-bf76-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30mg, 60mg and 90mg
50090-4249-22023-01-30C16284748780-1f386c649-bf76-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30mg, 60mg and 90mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4249-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-4249-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
50090-4249-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4249NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20200225_18c37b07-aaa3-4285-b2d7-7e81099dea9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN18c37b07-aaa3-4285-b2d7-7e81099dea9e3
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD18c37b07-aaa3-4285-b2d7-7e81099dea9e3
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY18c37b07-aaa3-4285-b2d7-7e81099dea9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4249-05009042490030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4249-0) 2019-04-030000-00-00NoNoCurrent
50090-4249-150090424901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4249-1) 2019-04-030000-00-00NoNoCurrent
50090-4249-25009042490290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4249-2) 2019-04-030000-00-00NoNoCurrent