FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
71335-2563
11-digit product format
713352563
Labeler code
71335
Product ID
71335-2563_b50bf86a-23d9-4354-91fe-697161c3bcd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202202
Marketing category
ANDA
Marketing start
2010-08-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2563-1Warfarin Sodium100 in 1 BOTTLETABLET1001
71335-2563-2Warfarin Sodium30 in 1 BOTTLETABLET301
71335-2563-3Warfarin Sodium45 in 1 BOTTLETABLET451
71335-2563-4Warfarin Sodium60 in 1 BOTTLETABLET601
71335-2563-5Warfarin Sodium15 in 1 BOTTLETABLET151
71335-2563-6Warfarin Sodium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2563WARFARIN SODIUM (WARFARIN) TABLET [BRYANT RANCH PREPACK]1Current NDC, 6 package rows20250130_8c876dd3-d659-479e-994c-39454c7028cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN8c876dd3-d659-479e-994c-39454c7028cc1
855332warfarin sodium 5 MG Oral TabletSCD8c876dd3-d659-479e-994c-39454c7028cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2563-171335256301100 TABLET in 1 BOTTLE (71335-2563-1) 100 tablet2025-01-28NoNoHistorical
71335-2563-27133525630230 TABLET in 1 BOTTLE (71335-2563-2) 30 tablet2025-01-28NoNoHistorical
71335-2563-37133525630345 TABLET in 1 BOTTLE (71335-2563-3) 45 tablet2025-01-28NoNoHistorical
71335-2563-47133525630460 TABLET in 1 BOTTLE (71335-2563-4) 60 tablet2025-01-28NoNoHistorical
71335-2563-57133525630515 TABLET in 1 BOTTLE (71335-2563-5) 15 tablet2025-01-28NoNoHistorical
71335-2563-67133525630690 TABLET in 1 BOTTLE (71335-2563-6) 90 tablet2025-01-28NoNoHistorical