Warfarin Sodium

Product NDC
51407-791
11-digit product format
514070791
Labeler code
51407
Product ID
51407-791_399997c4-911d-fe1e-e063-6294a90a9dd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040301-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004AB1fd3edfee7708…

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 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
ba8b4ead-d080-91e7-e053-2995a90a82feAvailable 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
51407-791-01Warfarin Sodium100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-791-01EA - Each51407-79117d47676-2583-453d-9f91-8be92b1e805a12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-791WARFARIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 1 package rows20240307_ba8b4ead-d080-91e7-e053-2995a90a82fe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
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
ndc (product): 51407-791
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855296warfarin sodium 10 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855302warfarin sodium 2 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855312warfarin sodium 2.5 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855318warfarin sodium 3 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855324warfarin sodium 4 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855332warfarin sodium 5 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855338warfarin sodium 6 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855344warfarin sodium 7.5 MG Oral TabletPSNba8b4ead-d080-91e7-e053-2995a90a82fe5
855288warfarin sodium 1 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855296warfarin sodium 10 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855302warfarin sodium 2 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855312warfarin sodium 2.5 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855318warfarin sodium 3 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855324warfarin sodium 4 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855332warfarin sodium 5 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855338warfarin sodium 6 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5
855344warfarin sodium 7.5 MG Oral TabletSCDba8b4ead-d080-91e7-e053-2995a90a82fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-791-0151407079101100 TABLET in 1 BOTTLE (51407-791-01) 100 tablet2021-02-020000-00-00NoNoCurrent