Nifedipine

Product NDC
64725-2057
11-digit product format
647252057
Labeler code
64725
Product ID
64725-2057_70bd0f0c-73c3-4b70-8fed-7bcd87723d1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA075269
Marketing category
ANDA
Marketing start
2012-10-18
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
E
Listing certified through
2017-12-31
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
64725-2057-12020-01-31C16284748780-19d75b9d0-394f-f424-e053-dadaa90a57ceNifedipine Extended-Release Tablets, USP 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-2057-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NifedipineACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
NifedipineACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5NIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688NIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-2057NIFEDIPINE TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_fa950a8e-06b7-4adf-ab5d-fe485772a850.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNfa950a8e-06b7-4adf-ab5d-fe485772a8502
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDfa950a8e-06b7-4adf-ab5d-fe485772a8502
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYfa950a8e-06b7-4adf-ab5d-fe485772a8502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-2057-164725205701100 in 1 BOTTLEHistorical