Nifedipine

Product NDC
66267-831
11-digit product format
662670831
Labeler code
66267
Product ID
66267-831_1fa79245-277f-9b81-e063-6294a90ab7cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA072781
Marketing category
ANDA
Marketing start
2009-08-11
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

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
66267-831-042024-08-14C16284748780-1f386c649-cc7f-0266-e053-dadaa90a7c1aNifedipine Capsules
66267-831-042023-01-30C16284748780-1f386c649-cc7f-0266-e053-dadaa90a7c1aNifedipine Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-831-04Nifedipine4 in 1 BOTTLECAPSULE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-831NIFEDIPINE CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240815_9b0263a7-c492-40ea-e053-2a95a90a561e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN9b0263a7-c492-40ea-e053-2a95a90a561e3
198032nifedipine 10 MG Oral CapsuleSCD9b0263a7-c492-40ea-e053-2a95a90a561e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-831-04662670831044 CAPSULE in 1 BOTTLE (66267-831-04) 4 capsule2019-12-310000-00-00NoNoCurrent