Nifedipine

Product NDC
70518-2679
11-digit product format
705182679
Labeler code
70518
Product ID
70518-2679_4a7dc836-cfa3-7c70-e063-6394a90a0df1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210614
Marketing category
ANDA
Marketing start
2020-04-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2679-0Nifedipine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2679NIFEDIPINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 1 package rows20250327_24e56333-5601-48fd-a263-f6be90983fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN24e56333-5601-48fd-a263-f6be90983fb410
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD24e56333-5601-48fd-a263-f6be90983fb410
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY24e56333-5601-48fd-a263-f6be90983fb410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2679-07051826790030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2679-0) 2020-04-080000-00-00NoNoCurrent