Nifedipine

Product NDC
68071-2838
11-digit product format
680712838
Labeler code
68071
Product ID
68071-2838_27d6c9c5-5a46-9cfc-e063-6394a90a7202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213361
Marketing category
ANDA
Marketing start
2021-07-19
Substance
NIFEDIPINE
Active strength
30 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
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198034

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
68071-2838-3Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2838NIFEDIPINE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20241127_27d6c9c5-5a45-9cfc-e063-6394a90a7202.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN27d6c9c5-5a45-9cfc-e063-6394a90a72021
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD27d6c9c5-5a45-9cfc-e063-6394a90a72021
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY27d6c9c5-5a45-9cfc-e063-6394a90a72021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2838-36807128380330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2838-3) 2022-12-08NoNoCurrent