FDA.reportPublic FDA data

NIFEDIPINE

Product NDC
54458-950
11-digit product format
544580950
Labeler code
54458
Product ID
54458-950_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
2009-08-21
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
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
54458-950-102020-01-31C16284748780-19d75b9d0-e392-f424-e053-dadaa90a57ceNifedipine Extended-release Tablets, USP For Oral Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-950-10NIFEDIPINE30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-950-10EA - Each54458-950dfe2b18e-72ea-480f-965d-3aebcb68ff9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, EXTENDED RELEASE [INTERNATIONAL LABORATORIES, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-950NIFEDIPINE 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
54458-950-105445809501030 in 1 BLISTER PACKHistorical