FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-029
11-digit product format
433530029
Labeler code
43353
Product ID
43353-029_49001c15-cda7-00e5-e063-6394a90a0853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090935
Marketing category
ANDA
Marketing start
2015-04-08
Substance
WARFARIN SODIUM
Active strength
2.5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A090935-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2011-05-25
A090935-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2011-05-25
A090935-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25
A090935-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2011-05-25
A090935-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2011-05-25
A090935-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2011-05-25
A090935-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2011-05-25
A090935-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25
A090935-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2011-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090935-001AB
A090935-002AB
A090935-003AB
A090935-004AB
A090935-005AB
A090935-006AB
A090935-007AB
A090935-008AB
A090935-009AB

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 06:07:402026-07A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25fd3edfee7708…

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 06:07:402026-07A090935-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090935-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090935-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-004AB1fd3edfee7708…

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6153CWM0CLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855288Internal RxNorm lookup
855296Internal RxNorm lookup
855302Internal RxNorm lookup
855312Internal RxNorm lookup
855318Internal RxNorm lookup
855324Internal RxNorm lookup
855332Internal RxNorm lookup
855344Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f276251-49b7-438f-9c47-f1cdfc47e519Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-029-30Warfarin Sodium30 in 1 BOTTLETABLET303
43353-029-35Warfarin Sodium35 in 1 BOTTLETABLET353
43353-029-40Warfarin Sodium40 in 1 BOTTLETABLET403
43353-029-45Warfarin Sodium45 in 1 BOTTLETABLET453
43353-029-53Warfarin Sodium60 in 1 BOTTLETABLET603
43353-029-60Warfarin Sodium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-029-30EA - Each43353-029710bbe68-996e-4ca1-9b44-7e0aa25cdb2a12016-07-19
43353-029-35EA - Each43353-029cf8a85d7-342e-4e2b-b806-a9b257f80b2412016-07-19
43353-029-40EA - Each43353-0299766e471-6f39-4fd3-90df-1059be67843312016-07-19
43353-029-45EA - Each43353-029ae2ebad1-f403-43c6-ae97-41af5eeae44512016-07-19
43353-029-53EA - Each43353-029f335e55e-c46e-44f8-a9a8-6d3b3c6d0a0e12016-07-19
43353-029-60EA - Each43353-02966eb1a7d-c3a9-4a43-af06-2517ba29c44012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-029WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 6 package rows20170711_4f276251-49b7-438f-9c47-f1cdfc47e519.zip

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC4f276251-49b7-438f-9c47-f1cdfc47e5192026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 43353-029
Warfarin SodiumWARFARINGolden State Medical Supply, Inc.a2f6c9f7-87dc-7428-e053-2995a90a1de62025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
WARFARIN SODIUMWARFARIN SODIUMDIRECT RXc186d1ff-64dd-bfcb-e053-2a95a90af8002025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC52b3c2f6-b5ca-44ae-bdcc-552d5191034f2021-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLCa98916a5-cdb2-4251-bdea-0245c763b2f12020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
Warfarin SodiumWARFARINExelan Pharmaceuticals Inc.c0cc4511-e656-4b6d-96cd-e02e76173b9d2020-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC91f24482-d4cb-4a09-a97e-64f6e49071ee2020-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855288warfarin sodium 1 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-029-304335300293030 TABLET in 1 BOTTLE (43353-029-30) 30 tablet2015-05-040000-00-00NoNoCurrent
43353-029-354335300293535 TABLET in 1 BOTTLE (43353-029-35) 35 tablet2015-05-240000-00-00NoNoCurrent
43353-029-404335300294040 TABLET in 1 BOTTLE (43353-029-40) 40 tablet2015-05-040000-00-00NoNoCurrent
43353-029-454335300294545 TABLET in 1 BOTTLE (43353-029-45) 45 tablet2015-05-040000-00-00NoNoCurrent
43353-029-534335300295360 TABLET in 1 BOTTLE (43353-029-53) 60 tablet2015-05-170000-00-00NoNoCurrent
43353-029-604335300296090 TABLET in 1 BOTTLE (43353-029-60) 90 tablet2015-05-040000-00-00NoNoCurrent