FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
50090-1211
11-digit product format
500901211
Labeler code
50090
Product ID
50090-1211_ee453990-95ba-4cc4-9999-bd3f4a9bf0bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Substance
WARFARIN SODIUM
Active strength
2 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC]; Vitamin K Inhibitors [MoA]
Listing certified through
2027-12-31
Current FDA listing
Yes

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.

Product history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-008AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-009AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040301-004AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM2 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855302Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
991b1e3e-236e-44cf-ad61-7233f777ce67Available on FDA.report

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 · 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
ndc (product): 50090-1211
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
50090-1211-05009012110030 TABLET in 1 BOTTLE (50090-1211-0)30 tablet2014-11-280Current