Warfarin Sodium

Product NDC
70518-2395
11-digit product format
705182395
Labeler code
70518
Product ID
70518-2395_4a16ce66-f7bf-0dbb-e063-6394a90ac907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202202
Marketing category
ANDA
Marketing start
2019-10-28
Substance
WARFARIN SODIUM
Active strength
4 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

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2395-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2395-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2395-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2395-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2395-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2395-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2395-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2395-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2395-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2395-0557ba5c1ecfa…9c80585c8c6e…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM4 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
855324Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
545ec40d-2db1-4581-b3ec-ce195e5f5400Available 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
70518-2395-0Warfarin Sodium100 in 1 BOXTABLET1006
70518-2395-1Warfarin Sodium1 in 1 POUCHTABLET16

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
ndc (product): 70518-2395
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855324warfarin sodium 4 MG Oral TabletPSN545ec40d-2db1-4581-b3ec-ce195e5f54006
855324warfarin sodium 4 MG Oral TabletSCD545ec40d-2db1-4581-b3ec-ce195e5f54006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2395-070518239500100 POUCH in 1 BOX (70518-2395-0) / 1 TABLET in 1 POUCH (70518-2395-1) 100 pouch2019-10-280000-00-00NoNoCurrent
70518-2395-1705182395011 in 1 POUCHHistorical
70518-2395-27051823950230 TABLET in 1 BLISTER PACK (70518-2395-2)30 tablet2026-06-250Current