NIFEDIPINE

Product NDC
54458-948
11-digit product format
544580948
Labeler code
54458
Product ID
54458-948_1211a605-ca29-47c7-9ba9-4170fd533722
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIFEDIPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077127
Marketing category
ANDA
Marketing start
2009-08-22
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
54458-948-082020-01-31C16284748780-19d75b9d0-e392-f424-e053-dadaa90a57ceNifedipine Extended-release Tablets, USP For Oral Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-948-08NIFEDIPINE30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-948NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, LLC]19Legacy NDC, 1 package rows20170609_453ac443-4fd4-4b5c-b7b4-06d34dc38e0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY453ac443-4fd4-4b5c-b7b4-06d34dc38e0d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-948-085445809480830 in 1 BLISTER PACKHistorical