Nifedipine

Product NDC
70518-3520
11-digit product format
705183520
Labeler code
70518
Product ID
70518-3520_3ab0218c-6abe-5399-e063-6394a90a9332
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210614
Marketing category
ANDA
Marketing start
2022-09-14
Substance
NIFEDIPINE
Active strength
60 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
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812013

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
70518-3520-0Nifedipine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3520NIFEDIPINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 1 package rows20240116_832fc274-605a-4b04-b327-dbf361131621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN832fc274-605a-4b04-b327-dbf3611316214
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD832fc274-605a-4b04-b327-dbf3611316214
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY832fc274-605a-4b04-b327-dbf3611316214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3520-07051835200030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3520-0) 2022-09-140000-00-00NoNoCurrent