Warfarin Sodium

Product NDC
50436-6364
11-digit product format
504366364
Labeler code
50436
Product ID
50436-6364_c8ca0e56-72a0-4be3-b151-ac45b587536f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-07-22
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
6 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-6364DDiscontinued by firm2026-08-10
excluded packagepackage50436-636450436-6364-1DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-6364-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-6364-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-6364-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-6364-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-6364-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-6364-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-6364-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-6364-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-6364-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-6364-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-6364-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-6364-1557ba5c1ecfa…9c80585c8c6e…

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
A040616-001WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2006-07-05
A040616-002WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05
A040616-003WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2006-07-05
A040616-004WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2006-07-05
A040616-005WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2006-07-05
A040616-006WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2006-07-05
A040616-007WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05
A040616-008WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05
A040616-009WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040616-001AB
A040616-002AB
A040616-003AB
A040616-004AB
A040616-005AB
A040616-006AB
A040616-007AB
A040616-008AB
A040616-009AB

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 UTC2026-02A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05b8a1b40f171c…

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 UTC2026-02A040616-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040616-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-008AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-009AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-004AB1b8a1b40f171c…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.724b0061-f42a-4008-a078-09c800ee97852026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.f5fb1a5f-0dda-4f47-8683-ea63ac88a69d2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.1244c338-9140-425a-bf2a-9da6b4ac02872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.d6083d68-4360-4d47-a1b2-1eb2763024bb2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.4dc2d94e-f856-47da-9d44-24773d97eb872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.ba65ae56-ca3b-4895-9938-1dde2c3d34bf2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.3f1c3083-91d1-488c-ad07-b198fda21da62026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.748ebea5-c65b-4b5a-b237-f4eb880865fa2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.b1bd0d02-eccb-4449-82b9-9b552835029e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32d3578-0c90-567c-e053-2a95a90a23b82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32dd451-3f7a-815b-e053-2995a90a528f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf86fe457-a1b6-e54d-e053-6294a90a9bc72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack3aeb6bb1-bc43-4fe7-83f2-36cd0bf461022025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack8eae6b6c-1851-4342-b320-7e18968946582025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacka1860448-d4ef-40f2-b096-056429ca3aea2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepackd166f83b-7052-4dc7-b7d4-47faae7dcaed2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacke7f78a33-71eb-4aac-ba9d-70f75136fab02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMPD-Rx Pharmaceuticals, Inc.21255cd5-3c2e-4574-9620-9347d14256b32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack4f8afe14-897c-458b-b76f-9bae6fa6110e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack44077bb7-6007-4c15-bbcd-a7a02ac081ce2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616