FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
51672-4031
Requested package NDC
51672-4031-0
11-digit product format
516724031
Labeler code
51672
Product ID
51672-4031_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
4 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-403151672-4031-0DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040301-001WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB1999-07-15
A040301-002WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB1999-07-15
A040301-003WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB1999-07-15
A040301-004WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15
A040301-005WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB1999-07-15
A040301-006WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB1999-07-15
A040301-007WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB1999-07-15
A040301-008WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB1999-07-15
A040301-009WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-productTE code
A040301-001AB
A040301-002AB
A040301-003AB
A040301-004AB
A040301-005AB
A040301-006AB
A040301-007AB
A040301-008AB
A040301-009AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15a50c72e98297…
2026-08-01 22:54:322026-06A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040301-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-007AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-008AB1a50c72e98297…
2026-08-01 22:54:322026-06A040301-009AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions8cd0e744-b499-4344-b1db-59f85950e1692026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions991b1e3e-236e-44cf-ad61-7233f777ce672026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.6b227c9e-02e9-4ec9-8b11-3ab6fe5093e52026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.72d3ea20-27e4-4368-a666-a9b76530dbb92026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.61ab23a7-bc67-4777-854a-bf43c788a69a2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.7b3b6f89-1feb-4939-a95b-7ad0707f4d762026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.73b8e5ab-86f8-44f8-b290-346acb81c9ae2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLCcdbbc317-35d3-42ba-94f0-c838913585292025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack694e258d-86bd-440c-870b-a7d27fb1c4672025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMGolden State Medical Supply, Inc.ba8b4ead-d080-91e7-e053-2995a90a82fe2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMSun Pharmaceutical Industries, Inc.8ad881e0-ca41-42ad-9d7d-eb85b3a30af02025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (package): 51672-4031-0
ndc (product): 51672-4031
ndc11 (package): 51672403100
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingab047628-67d0-4a64-8d77-36b054969b442024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingfeaa5f6f-9753-4f37-ab81-04c9c6b45e6a2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLCe73d37f8-8a28-4d93-9529-fd1e2c84228a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLC2c8f47c6-a180-4ad8-b962-04069d2270cb2021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6153CWM0CLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855288Internal RxNorm lookup
855296Internal RxNorm lookup
855302Internal RxNorm lookup
855312Internal RxNorm lookup
855318Internal RxNorm lookup
855324Internal RxNorm lookup
855332Internal RxNorm lookup
855338Internal RxNorm lookup
855344Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ad881e0-ca41-42ad-9d7d-eb85b3a30af0Available on FDA.report

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
51672-4031-0Warfarin Sodium10 in 1 BLISTER PACKTABLET1014
51672-4031-0Warfarin Sodium10 in 1 CARTONTABLET1014
51672-4031-1Warfarin Sodium100 in 1 BOTTLETABLET10014
51672-4031-3Warfarin Sodium1000 in 1 BOTTLETABLET100014
51672-4031-7Warfarin Sodium5000 in 1 BOTTLETABLET500014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4031-1EA - Each51672-40314b6beccb-4418-43cf-b8ed-cd8bc68a1d2912012-07-24
51672-4031-3EA - Each51672-4031ee68b21a-50a3-4315-a10c-8622b87bee2412012-07-24
51672-4031-7EA - Each51672-40313c59749c-c230-4bbd-bc84-1abbd2d6505e12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4031WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy NDC, 5 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4031-05167240310010 BLISTER PACK in 1 CARTON (51672-4031-0) > 10 TABLET in 1 BLISTER PACK10 blister pack1999-07-150000-00-00NoNoCurrent