Nifedipine

Product NDC
55154-4690
11-digit product format
551544690
Labeler code
55154
Product ID
55154-4690_1d81d58f-5ade-48e0-a8ee-460b7cf7c17d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077127
Marketing category
ANDA
Marketing start
2012-05-24
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, 1812013

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
55154-4690-0Nifedipine10 in 1 BAGTABLET, FILM COATED, EXTENDED RE108
55154-4690-0Nifedipine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4690NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20250122_593d8ca3-c303-4512-96a6-d4860e02cd83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN593d8ca3-c303-4512-96a6-d4860e02cd838
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN593d8ca3-c303-4512-96a6-d4860e02cd838
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD593d8ca3-c303-4512-96a6-d4860e02cd838
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD593d8ca3-c303-4512-96a6-d4860e02cd838
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY593d8ca3-c303-4512-96a6-d4860e02cd838
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY593d8ca3-c303-4512-96a6-d4860e02cd838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4690-05515446900010 BLISTER PACK in 1 BAG (55154-4690-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2012-05-240000-00-00NoNoCurrent