Nifedipine

Product NDC
68071-2619
11-digit product format
680712619
Labeler code
68071
Product ID
68071-2619_2a0755bc-c7fb-a5df-e063-6294a90ac4a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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
Rxcui1812011

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
68071-2619-3Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
68071-2619-9Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2619NIFEDIPINE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20241226_d5df10bc-16ed-7a97-e053-2a95a90ab15e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNd5df10bc-16ed-7a97-e053-2a95a90ab15e2
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDd5df10bc-16ed-7a97-e053-2a95a90ab15e2
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYd5df10bc-16ed-7a97-e053-2a95a90ab15e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2619-36807126190330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2619-3) 2022-01-180000-00-00NoNoCurrent
68071-2619-96807126190990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2619-9) 2022-01-180000-00-00NoNoCurrent