Warfarin Sodium

Product NDC
50090-5440
Requested package NDC
50090-5440-0
11-digit product format
500905440
Labeler code
50090
Product ID
50090-5440_2f23e738-86d1-4c87-8dc4-325073723e92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-04-07
Substance
WARFARIN SODIUM
Active strength
5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A040616-001WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2006-07-05
A040616-002WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05
A040616-003WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2006-07-05
A040616-004WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2006-07-05
A040616-005WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2006-07-05
A040616-006WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2006-07-05
A040616-007WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05
A040616-008WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05
A040616-009WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040616-001AB
A040616-002AB
A040616-003AB
A040616-004AB
A040616-005AB
A040616-006AB
A040616-007AB
A040616-008AB
A040616-009AB

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 UTC2026-02A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05b8a1b40f171c…

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 UTC2026-02A040616-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040616-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040616-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040616-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040616-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-008AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040616-009AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040616-004AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855332Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35bf53df-994b-4c32-8bdb-9227e8e195c6Available on FDA.report

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
50090-5440-0Warfarin Sodium90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5440-0EA - Each50090-5440a636ae80-db44-42f0-97a4-e0f525d2231312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5440WARFARIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230831_35bf53df-994b-4c32-8bdb-9227e8e195c6.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.724b0061-f42a-4008-a078-09c800ee97852026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.f5fb1a5f-0dda-4f47-8683-ea63ac88a69d2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.1244c338-9140-425a-bf2a-9da6b4ac02872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.d6083d68-4360-4d47-a1b2-1eb2763024bb2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.4dc2d94e-f856-47da-9d44-24773d97eb872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.ba65ae56-ca3b-4895-9938-1dde2c3d34bf2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.3f1c3083-91d1-488c-ad07-b198fda21da62026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.748ebea5-c65b-4b5a-b237-f4eb880865fa2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.b1bd0d02-eccb-4449-82b9-9b552835029e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32d3578-0c90-567c-e053-2a95a90a23b82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32dd451-3f7a-815b-e053-2995a90a528f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf86fe457-a1b6-e54d-e053-6294a90a9bc72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack3aeb6bb1-bc43-4fe7-83f2-36cd0bf461022025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack8eae6b6c-1851-4342-b320-7e18968946582025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacka1860448-d4ef-40f2-b096-056429ca3aea2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepackd166f83b-7052-4dc7-b7d4-47faae7dcaed2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacke7f78a33-71eb-4aac-ba9d-70f75136fab02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMPD-Rx Pharmaceuticals, Inc.21255cd5-3c2e-4574-9620-9347d14256b32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack4f8afe14-897c-458b-b76f-9bae6fa6110e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack44077bb7-6007-4c15-bbcd-a7a02ac081ce2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040616
application number: ANDA040616

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN35bf53df-994b-4c32-8bdb-9227e8e195c64
855332warfarin sodium 5 MG Oral TabletSCD35bf53df-994b-4c32-8bdb-9227e8e195c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5440-05009054400090 TABLET in 1 BOTTLE (50090-5440-0) 90 tablet2021-01-200000-00-00NoNoCurrent