Nifedipine

Product NDC
0228-2497
11-digit product format
002282497
Labeler code
0228
Product ID
0228-2497_f5799caf-c875-46f7-a23b-092a54872b30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072579
Marketing category
ANDA
Marketing start
1991-01-01
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
10 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
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2497-10EA - Each0228-2497be7a87c3-86eb-46a9-ae65-8bf9a69dbd1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]3
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE, LIQUID FILLED [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN5733e038-7cb5-434b-aa8e-abb25e6252c93
198033NIFEdipine 20 MG Oral CapsulePSN5733e038-7cb5-434b-aa8e-abb25e6252c93
198032nifedipine 10 MG Oral CapsuleSCD5733e038-7cb5-434b-aa8e-abb25e6252c93
198033nifedipine 20 MG Oral CapsuleSCD5733e038-7cb5-434b-aa8e-abb25e6252c93
198032NIFEdipine 10 MG Oral CapsulePSN0d592c37-b38c-4fb6-a1d3-96531384ae8d1
198032nifedipine 10 MG Oral CapsuleSCD0d592c37-b38c-4fb6-a1d3-96531384ae8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2497-1000228249710100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0228-2497-10) 1991-01-010000-00-00NoNoCurrent