FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
50090-5440
11-digit product format
500905440
Labeler code
50090
Product ID
50090-5440_2f23e738-86d1-4c87-8dc4-325073723e92
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
2015-04-07
Substance
WARFARIN SODIUM
Active strength
5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855332

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
50090-5440-02023-02-07C16284748780-1f386c649-afdf-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
50090-5440-02023-01-30C16284748780-1f386c649-afdf-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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5440-0Warfarin Sodium90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5440-0EA - Each50090-5440a636ae80-db44-42f0-97a4-e0f525d2231312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5440WARFARIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230831_35bf53df-994b-4c32-8bdb-9227e8e195c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN35bf53df-994b-4c32-8bdb-9227e8e195c64
855332warfarin sodium 5 MG Oral TabletSCD35bf53df-994b-4c32-8bdb-9227e8e195c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5440-05009054400090 TABLET in 1 BOTTLE (50090-5440-0) 90 tablet2021-01-200000-00-00NoNoCurrent