FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-6732
11-digit product format
500906732
Labeler code
50090
Product ID
50090-6732_84e4e78e-7b15-455a-934c-7a091dd95b95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216067
Marketing category
ANDA
Marketing start
2022-03-30
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6732-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-6732-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
50090-6732-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6732NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231016_5a7951e7-f507-43e8-9bba-855b79daf170.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN5a7951e7-f507-43e8-9bba-855b79daf1703
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD5a7951e7-f507-43e8-9bba-855b79daf1703
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY5a7951e7-f507-43e8-9bba-855b79daf1703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6732-05009067320030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-0) 2023-10-06NoNoCurrent
50090-6732-150090673201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-1) 2023-10-06NoNoCurrent
50090-6732-25009067320290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-2) 2023-10-06NoNoCurrent