Nifedipine

Product NDC
49884-677
11-digit product format
498840677
Labeler code
49884
Product ID
49884-677_be0ad7fd-6e38-496c-969c-7f4633295f20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA077899
Marketing category
ANDA
Marketing start
2007-06-22
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-677-01EA - Each49884-677a4c1e93e-1e39-432d-8324-b87903af29b112013-02-13
49884-677-05EA - Each49884-677e55ae771-88ae-4e8a-bd37-ba53f38a40fa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN6e740c6e-483b-4e7d-833f-2e8bdd36d6251
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD6e740c6e-483b-4e7d-833f-2e8bdd36d6251
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY6e740c6e-483b-4e7d-833f-2e8bdd36d6251