FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-6450
11-digit product format
500906450
Labeler code
50090
Product ID
50090-6450_2ce3a41d-f477-45a5-b48a-fae752ec9c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
Substance
NIFEDIPINE
Active strength
90 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
NIFEDIPINE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812015

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
50090-6450-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-6450-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6450NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230502_9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6450-05009064500030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6450-0) 2023-04-27NoNoCurrent
50090-6450-25009064500290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6450-2) 2023-04-27NoNoCurrent