Warfarin Sodium

Product NDC
65841-059
11-digit product format
658410059
Labeler code
65841
Product ID
65841-059_d574b623-3aee-4c1f-b85b-e9e51d388286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA040663
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct65841-059DDiscontinued by firm2026-08-17
excluded packagepackage65841-05965841-059-01DDiscontinued by firm2026-08-17

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 · 4 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 packagepackage65841-059-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65841-059-01f5e01cc5f278…a2eaf40c39c3…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-059WARFARIN SODIUM TABLET [ZYDUS LIFESCIENCES LIMITED]8Legacy NDC20231005_3fb2aa58-3a40-4255-a261-e2db5b9a5dde.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-059-0165841005901100 TABLET in 1 BOTTLE (65841-059-01) 100 tablet2006-06-190000-00-00NoNoCurrent