FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-4158
11-digit product format
500904158
Labeler code
50090
Product ID
50090-4158_adf82f3c-0a13-4913-a4e3-3fbdd8d95a62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077127
Marketing category
ANDA
Marketing start
2007-10-03
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4158-02023-04-20C16284748780-1f386c649-fd9b-0266-e053-dadaa90a7c1aNIFEedipine Extended-release Tablets, USP
50090-4158-02023-01-30C16284748780-1f386c649-fd9b-0266-e053-dadaa90a7c1aNIFEedipine Extended-release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4158-0Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
50090-4158-1Nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
50090-4158-2Nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4158-0EA - Each50090-41584786ab30-b626-4174-87b3-8c0c6657585912022-01-06
50090-4158-2EA - Each50090-4158ef43d9df-5111-4c3e-94c5-5ce7af07f72a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4158NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 3 package rows20230519_ec13ec71-626f-4664-b264-f67ba72071ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNec13ec71-626f-4664-b264-f67ba72071ae6
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDec13ec71-626f-4664-b264-f67ba72071ae6
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYec13ec71-626f-4664-b264-f67ba72071ae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4158-05009041580030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4158-0) 2019-02-250000-00-00NoNoCurrent
50090-4158-150090415801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4158-1) 2023-04-14NoNoCurrent
50090-4158-25009041580290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4158-2) 2023-04-14NoNoCurrent