Nifedipine

Product NDC
23155-194
11-digit product format
231550194
Labeler code
23155
Product ID
23155-194_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
10 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
NIFEDIPINE10 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
23155-194-01Nifedipine100 in 1 BOTTLECAPSULE10017
23155-194-13Nifedipine300 in 1 BOTTLECAPSULE30017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-194NIFEDIPINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20230804_b8b8cfee-ea71-44c2-81af-675efecfdf15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN51cdb22b-035f-47d7-8048-38006e2589f221
198032nifedipine 10 MG Oral CapsuleSCD51cdb22b-035f-47d7-8048-38006e2589f221
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
198032NIFEdipine 10 MG Oral CapsulePSNacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032nifedipine 10 MG Oral CapsuleSCDacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032NIFEdipine 10 MG Oral CapsulePSNbddfd658-ac61-4ba2-a3fa-07acc35d368a1
198032nifedipine 10 MG Oral CapsuleSCDbddfd658-ac61-4ba2-a3fa-07acc35d368a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-194-0123155019401100 CAPSULE in 1 BOTTLE (23155-194-01) 100 capsule2010-12-070000-00-00NoNoCurrent
23155-194-1323155019413300 CAPSULE in 1 BOTTLE (23155-194-13) 300 capsule2010-12-070000-00-00NoNoCurrent