FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
50090-5004
11-digit product format
500905004
Labeler code
50090
Product ID
50090-5004_776ea037-7f84-43d0-ade4-55e8a70ef9bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040616
Marketing category
ANDA
Marketing start
2018-08-27
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
8 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5004-02023-02-07C16284748780-1f386c64a-3558-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
50090-5004-12023-02-07C16284748780-1f386c64a-3558-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
50090-5004-02023-01-30C16284748780-1f386c64a-3558-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
50090-5004-12023-01-30C16284748780-1f386c64a-3558-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5004WARFARIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC20230208_b2728b7c-ae6e-49f6-b21b-335db78f4c49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5004-05009050040030 TABLET in 1 BOTTLE (50090-5004-0) 30 tablet2020-04-140000-00-00NoNoCurrent
50090-5004-15009050040190 TABLET in 1 BOTTLE (50090-5004-1) 90 tablet2020-04-140000-00-00NoNoCurrent