Nifedipine

Product NDC
55154-4157
11-digit product format
551544157
Labeler code
55154
Product ID
55154-4157_fbed5c6d-c2d1-43d8-a15a-365315a57b65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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
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
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
55154-4157-0Nifedipine1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE14
55154-4157-0Nifedipine10 in 1 BAGTABLET, EXTENDED RELEASE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4157NIFEDIPINE TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20250116_c98ecf77-ae9a-438b-9bad-ffbed25d95bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNc98ecf77-ae9a-438b-9bad-ffbed25d95bc4
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDc98ecf77-ae9a-438b-9bad-ffbed25d95bc4
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYc98ecf77-ae9a-438b-9bad-ffbed25d95bc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4157-05515441570010 BLISTER PACK in 1 BAG (55154-4157-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2022-05-120000-00-00NoNoCurrent