Nifedipine

Product NDC
23155-195
11-digit product format
231550195
Labeler code
23155
Product ID
23155-195_b9bbf7c7-2447-4cb1-a0c2-662a9d01d6d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202644
Marketing category
ANDA
Marketing start
2010-12-07
Substance
NIFEDIPINE
Active strength
20 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198032, 198033

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-195-01Nifedipine100 in 1 BOTTLECAPSULE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-195-01EA - Each23155-19527d723d2-376d-418b-a419-4b114f5af22212013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-195NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 1 package rows20230804_b8b8cfee-ea71-44c2-81af-675efecfdf15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSNb8b8cfee-ea71-44c2-81af-675efecfdf1517
198033NIFEdipine 20 MG Oral CapsulePSNb8b8cfee-ea71-44c2-81af-675efecfdf1517
198032nifedipine 10 MG Oral CapsuleSCDb8b8cfee-ea71-44c2-81af-675efecfdf1517
198033nifedipine 20 MG Oral CapsuleSCDb8b8cfee-ea71-44c2-81af-675efecfdf1517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-195-0123155019501100 CAPSULE in 1 BOTTLE (23155-195-01) 100 capsule2010-12-070000-00-00NoNoCurrent