Warfarin Sodium

Product NDC
71335-2309
11-digit product format
713352309
Labeler code
71335
Product ID
71335-2309_fbf1e034-ee7f-4f4a-84d3-a5ea78fdd363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202202
Marketing category
ANDA
Marketing start
2010-08-16
Substance
WARFARIN SODIUM
Active strength
2 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 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
A202202-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2013-03-04
A202202-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2013-03-04
A202202-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-04
A202202-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2013-03-04
A202202-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2013-03-04
A202202-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2013-03-04
A202202-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2013-03-04
A202202-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2013-03-04
A202202-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2013-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202202-001AB
A202202-002AB
A202202-003AB
A202202-004AB
A202202-005AB
A202202-006AB
A202202-007AB
A202202-008AB
A202202-009AB

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 06:07:402026-07A202202-001WARFARIN SODIUM1MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-002WARFARIN SODIUM2MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-003WARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-004WARFARIN SODIUM3MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-005WARFARIN SODIUM4MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-006WARFARIN SODIUM5MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-007WARFARIN SODIUM6MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-008WARFARIN SODIUM7.5MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-009WARFARIN SODIUM10MGTABLET / ORALAB2013-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202202-001WARFARIN SODIUM1MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-002WARFARIN SODIUM2MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-003WARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-004WARFARIN SODIUM3MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-005WARFARIN SODIUM4MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-006WARFARIN SODIUM5MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-007WARFARIN SODIUM6MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-008WARFARIN SODIUM7.5MGTABLET / ORALAB2013-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-009WARFARIN SODIUM10MGTABLET / ORALAB2013-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-001WARFARIN SODIUM1MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-002WARFARIN SODIUM2MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-003WARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-004WARFARIN SODIUM3MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-005WARFARIN SODIUM4MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-006WARFARIN SODIUM5MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-007WARFARIN SODIUM6MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-008WARFARIN SODIUM7.5MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-009WARFARIN SODIUM10MGTABLET / ORALAB2013-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202202-001WARFARIN SODIUM1MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-002WARFARIN SODIUM2MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-003WARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-004WARFARIN SODIUM3MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-005WARFARIN SODIUM4MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-006WARFARIN SODIUM5MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-007WARFARIN SODIUM6MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-008WARFARIN SODIUM7.5MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-009WARFARIN SODIUM10MGTABLET / ORALAB2013-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-001WARFARIN SODIUM1MGTABLET / ORALAB2013-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-002WARFARIN SODIUM2MGTABLET / ORALAB2013-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-003WARFARIN SODIUM2.5MGTABLET / ORALAB2013-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-004WARFARIN SODIUM3MGTABLET / ORALAB2013-03-04fd3edfee7708…

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 06:07:402026-07A202202-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202202-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202202-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202202-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202202-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202202-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202202-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202202-004AB1fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM2 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
855302Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dd9f8ce-75e0-426a-9d22-6af7742a0ca7Available 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
71335-2309-1Warfarin Sodium30 in 1 BOTTLETABLET30100
71335-2309-2Warfarin Sodium14 in 1 BOTTLETABLET14100
71335-2309-3Warfarin Sodium90 in 1 BOTTLETABLET90100
71335-2309-4Warfarin Sodium45 in 1 BOTTLETABLET45100
71335-2309-5Warfarin Sodium50 in 1 BOTTLETABLET50100
71335-2309-6Warfarin Sodium21 in 1 BOTTLETABLET21100
71335-2309-7Warfarin Sodium60 in 1 BOTTLETABLET60100
71335-2309-8Warfarin Sodium20 in 1 BOTTLETABLET20100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2309WARFARIN SODIUM (WARFARIN) TABLET [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20231219_3dd9f8ce-75e0-426a-9d22-6af7742a0ca7.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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINA-S Medication Solutions541c9a70-adaf-4ef3-94ba-ad4e70dfa0572026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.d7fb4290-ed37-4ed3-ae51-c400191961dc2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.51e98fb6-ba76-497e-95d8-fe895ef0b7ed2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.a4cf3107-5646-4b91-8aae-94548e4409ef2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.2fb8b8d5-f643-4069-8e47-5eae31a8fbc82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.884cdbf6-0a52-4126-8e14-b0d7c9367e332026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.8eddba53-19c4-411b-b0d4-cb2f948ba1252026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.2cbcc99d-9107-4d39-a1e9-e19305de8b5d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.8ee94789-72d2-4c42-9dbd-0501e9767d972026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINREMEDYREPACK INC.545ec40d-2db1-4581-b3ec-ce195e5f54002026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINAmneal Pharmaceuticals LLC558b7a0d-5490-4c1b-802e-3ab3f1efe7602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINCoupler LLC52bacf1e-9ba8-7eca-e063-6394a90ab60b2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINCoupler LLC5256c518-31bf-f73b-e063-6394a90a71da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINCoupler LLC2f2119e8-f583-ba16-e063-6394a90a13a22025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINCoupler LLC2d58d204-4976-95cf-e063-6394a90a34b72025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINBryant Ranch Prepack8c876dd3-d659-479e-994c-39454c7028cc2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
WARFARIN SODIUMWARFARIN SODIUMDirect_Rxefded00a-22b9-1da7-e053-2995a90a58ca2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINPreferred Pharmaceuticals Inc.ac117f50-8e67-4203-8d97-e53dd0687c202025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINBryant Ranch Prepack7fdfd870-e72d-4d88-b6d9-1d711b66d09f2024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
Warfarin SodiumWARFARINBryant Ranch Prepack3dd9f8ce-75e0-426a-9d22-6af7742a0ca72023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202202
application number: ANDA202202
ndc (product): 71335-2309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855302warfarin sodium 2 MG Oral TabletPSN3dd9f8ce-75e0-426a-9d22-6af7742a0ca7100
855302warfarin sodium 2 MG Oral TabletSCD3dd9f8ce-75e0-426a-9d22-6af7742a0ca7100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2309-17133523090130 TABLET in 1 BOTTLE (71335-2309-1) 30 tablet2023-12-14NoNoCurrent
71335-2309-27133523090214 TABLET in 1 BOTTLE (71335-2309-2) 14 tablet2023-12-14NoNoCurrent
71335-2309-37133523090390 TABLET in 1 BOTTLE (71335-2309-3) 90 tablet2023-12-14NoNoCurrent
71335-2309-47133523090445 TABLET in 1 BOTTLE (71335-2309-4) 45 tablet2023-12-14NoNoCurrent
71335-2309-57133523090550 TABLET in 1 BOTTLE (71335-2309-5) 50 tablet2023-12-14NoNoCurrent
71335-2309-67133523090621 TABLET in 1 BOTTLE (71335-2309-6) 21 tablet2023-12-14NoNoCurrent
71335-2309-77133523090760 TABLET in 1 BOTTLE (71335-2309-7) 60 tablet2023-12-14NoNoCurrent
71335-2309-87133523090820 TABLET in 1 BOTTLE (71335-2309-8) 20 tablet2023-12-14NoNoCurrent