Warfarin Sodium

Product NDC
0555-0834
11-digit product format
005550834
Labeler code
0555
Product ID
0555-0834_6e0fe641-6c79-4f53-afc8-a87035eb0547
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040145
Marketing category
ANDA
Marketing start
1997-07-25
Marketing end
2020-04-30
Substance
WARFARIN SODIUM
Active strength
8 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0555-0834DDiscontinued by firm2026-10-05
excluded packagepackage0555-08340555-0834-02DDiscontinued by firm2026-10-05

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 packagepackage0555-0834-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0555-0834-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0555-0834-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0555-0834-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0555-0834-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0555-0834-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0555-0834-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0555-0834-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0555-0834-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0555-0834-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0555-0834-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0555-0834-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040145-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORAL1997-03-26
A040145-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORAL1997-03-26
A040145-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26
A040145-004WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORAL1997-03-26
A040145-005WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORAL1997-03-26
A040145-006WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26
A040145-007WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORAL1997-03-26
A040145-008WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORAL1998-11-05
A040145-009WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORAL1998-11-05

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 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-005WARFARIN SODIUM5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-006WARFARIN SODIUM7.5MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-007WARFARIN SODIUM10MGTABLET / ORAL1997-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-008WARFARIN SODIUM3MGTABLET / ORAL1998-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040145-009WARFARIN SODIUM6MGTABLET / ORAL1998-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040145-001WARFARIN SODIUM1MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-002WARFARIN SODIUM2MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-003WARFARIN SODIUM2.5MGTABLET / ORAL1997-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040145-004WARFARIN SODIUM4MGTABLET / ORAL1997-03-266a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-006AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-007AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-008AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040145-009AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040145-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-006AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-007AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-008AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040145-009AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-007AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-008AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040145-009AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040145-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-006AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-007AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-008AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040145-009AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040145-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040145-004AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0834-02EA - Each0555-08348f0d3681-1694-4fa6-bc93-de5f78dd977f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [BARR LABORATORIES INC.]9