FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
63629-4543
11-digit product format
636294543
Labeler code
63629
Product ID
63629-4543_ccaac18e-bb44-4d53-b127-f815859fada6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Substance
WARFARIN SODIUM
Active strength
10 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 SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855296

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
63629-4543-12024-05-21C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-22024-05-21C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-32024-05-21C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-12019-11-27C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-22019-11-27C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-32019-11-27C16284748780-19855e2a2-4446-60a7-e053-dbdaa90a05bdThese 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
63629-4543-1Warfarin Sodium30 in 1 BOTTLETABLET301003
63629-4543-2Warfarin Sodium60 in 1 BOTTLETABLET601003
63629-4543-3Warfarin Sodium90 in 1 BOTTLETABLET901003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4543WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1002Current NDC, Legacy NDC, 3 package rows20240523_694e258d-86bd-440c-870b-a7d27fb1c467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855296warfarin sodium 10 MG Oral TabletPSN694e258d-86bd-440c-870b-a7d27fb1c4671003
855296warfarin sodium 10 MG Oral TabletSCD694e258d-86bd-440c-870b-a7d27fb1c4671003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4543-16362945430130 TABLET in 1 BOTTLE (63629-4543-1) 30 tablet2011-07-22NoNoCurrent
63629-4543-26362945430260 TABLET in 1 BOTTLE (63629-4543-2) 60 tablet2024-05-21NoNoCurrent
63629-4543-36362945430390 TABLET in 1 BOTTLE (63629-4543-3) 90 tablet2013-01-22NoNoCurrent