Warfarin Sodium

Product NDC
50436-9946
11-digit product format
504369946
Labeler code
50436
Product ID
50436-9946_fde8e330-e3ac-4053-949d-652edd69c6b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040663
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
2 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 productproduct50436-9946IInactivated by FDA2026-08-17
excluded packagepackage50436-994650436-9946-2IInactivated by FDA2026-08-17

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 · 42 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 packagepackage50436-9946-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-9946-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-9946-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-9946-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-9946-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-9946-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-9946-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-9946-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-9946-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-9946-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-9946-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-9946-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-9946-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-9946-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-9946-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-9946-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-9946-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-9946-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-9946-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50436-9946-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50436-9946-29bebd1f3094a…5416666fcb17…

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
A040663-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2006-05-30
A040663-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2006-05-30
A040663-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30
A040663-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2006-05-30
A040663-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2006-05-30
A040663-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2006-05-30
A040663-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2006-05-30
A040663-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30
A040663-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2006-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040663-001AB
A040663-002AB
A040663-003AB
A040663-004AB
A040663-005AB
A040663-006AB
A040663-007AB
A040663-008AB
A040663-009AB

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 06:07:402026-07A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-30fd3edfee7708…

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 06:07:402026-07A040663-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040663-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040663-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040663-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040663-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040663-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040663-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-004AB1fd3edfee7708…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9946-2Warfarin Sodium30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9946WARFARIN SODIUM TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20131218_03845452-4ec4-4593-abdf-5a6cc8d241a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855302warfarin sodium 2 MG Oral TabletPSN03845452-4ec4-4593-abdf-5a6cc8d241a92
855302warfarin sodium 2 MG Oral TabletSCD03845452-4ec4-4593-abdf-5a6cc8d241a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9946-25043699460230 in 1 BOTTLEHistorical