Warfarin Sodium

Product NDC
63629-3177
Requested package NDC
63629-3177-1
11-digit product format
636293177
Labeler code
63629
Product ID
63629-3177_7e8a3a4e-87e5-43af-b041-df00b4c95fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040663
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
3 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-317763629-3177-1DDiscontinued by firm2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
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 · 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 UTC2026-02A040663-001WARFARIN 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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-005WARFARIN SODIUM4MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-006WARFARIN SODIUM5MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-007WARFARIN SODIUM6MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-008WARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-009WARFARIN SODIUM10MGTABLET / ORALAB2006-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-001WARFARIN SODIUM1MGTABLET / ORALAB2006-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-002WARFARIN SODIUM2MGTABLET / ORALAB2006-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-003WARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-004WARFARIN SODIUM3MGTABLET / ORALAB2006-05-30b8a1b40f171c…

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 UTC2026-02A040663-001AB1011fe1cb6892…
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-008AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040663-009AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040663-004AB1b8a1b40f171c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3177-12020-10-12These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-22020-10-12These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-32020-10-12These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-42020-10-12These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-52020-10-12These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-12020-01-31These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-22020-01-31These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-32020-01-31These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-42020-01-31These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
63629-3177-52020-01-31These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3177-1EA - Each63629-3177fdd8438f-e81e-4e10-a76a-c74f39c4ab2112012-07-24
63629-3177-2EA - Each63629-3177a2d9d273-547e-4d1c-8686-0e40c65e550d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3177-16362931770130 TABLET in 1 BOTTLE (63629-3177-1) 30 tablet2010-08-040000-00-00NoNoCurrent