FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
51672-4034
11-digit product format
516724034
Labeler code
51672
Product ID
51672-4034_373f3fe2-c159-028e-e063-6394a90aff59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Substance
WARFARIN SODIUM
Active strength
7.5 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 SODIUM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344

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
51672-4034-0Warfarin Sodium10 in 1 CARTONTABLET1014
51672-4034-0Warfarin Sodium10 in 1 BLISTER PACKTABLET1014
51672-4034-1Warfarin Sodium100 in 1 BOTTLETABLET10014
51672-4034-3Warfarin Sodium1000 in 1 BOTTLETABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4034-1EA - Each51672-40347861b756-0ba7-4d67-a3ba-5b1bce0bf7c712012-07-24
51672-4034-3EA - Each51672-40346b210b2f-ed6e-422c-8017-9e7b541f32b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4034WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy NDC, 4 package rows20231222_8ad881e0-ca41-42ad-9d7d-eb85b3a30af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855296warfarin sodium 10 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855302warfarin sodium 2 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855312warfarin sodium 2.5 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855318warfarin sodium 3 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855324warfarin sodium 4 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855332warfarin sodium 5 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855338warfarin sodium 6 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855344warfarin sodium 7.5 MG Oral TabletPSN8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855288warfarin sodium 1 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855296warfarin sodium 10 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855302warfarin sodium 2 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855312warfarin sodium 2.5 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855318warfarin sodium 3 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855324warfarin sodium 4 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855332warfarin sodium 5 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855338warfarin sodium 6 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855344warfarin sodium 7.5 MG Oral TabletSCD8ad881e0-ca41-42ad-9d7d-eb85b3a30af014
855288warfarin sodium 1 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855296warfarin sodium 10 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855302warfarin sodium 2 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855312warfarin sodium 2.5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855318warfarin sodium 3 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855324warfarin sodium 4 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855332warfarin sodium 5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855338warfarin sodium 6 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855344warfarin sodium 7.5 MG Oral TabletPSNb1b766b1-0327-48cd-ab01-e85038cf365f2
855288warfarin sodium 1 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855296warfarin sodium 10 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855302warfarin sodium 2 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855312warfarin sodium 2.5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855318warfarin sodium 3 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855324warfarin sodium 4 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855332warfarin sodium 5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855338warfarin sodium 6 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855344warfarin sodium 7.5 MG Oral TabletSCDb1b766b1-0327-48cd-ab01-e85038cf365f2
855288warfarin sodium 1 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855296warfarin sodium 10 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855302warfarin sodium 2 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855312warfarin sodium 2.5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855318warfarin sodium 3 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855332warfarin sodium 5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855344warfarin sodium 7.5 MG Oral TabletPSN61ab23a7-bc67-4777-854a-bf43c788a69a1
855344warfarin sodium 7.5 MG Oral TabletPSN06b0fad4-fb3d-497f-8bf1-8d8a79ac41641
855344warfarin sodium 7.5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855288warfarin sodium 1 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855296warfarin sodium 10 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855302warfarin sodium 2 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855312warfarin sodium 2.5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855318warfarin sodium 3 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855332warfarin sodium 5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855344warfarin sodium 7.5 MG Oral TabletSCD61ab23a7-bc67-4777-854a-bf43c788a69a1
855344warfarin sodium 7.5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855344warfarin sodium 7.5 MG Oral TabletSCD06b0fad4-fb3d-497f-8bf1-8d8a79ac41641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4034-05167240340010 BLISTER PACK in 1 CARTON (51672-4034-0) > 10 TABLET in 1 BLISTER PACK10 blister pack1999-07-150000-00-00NoNoCurrent
51672-4034-151672403401100 TABLET in 1 BOTTLE (51672-4034-1) 100 tablet1999-07-150000-00-00NoNoCurrent
51672-4034-3516724034031000 TABLET in 1 BOTTLE (51672-4034-3) 1000 tablet1999-07-150000-00-00NoNoCurrent