Warfarin Sodium

Product NDC
63629-4543
11-digit product format
636294543
Labeler code
63629
Product ID
63629-4543_ccaac18e-bb44-4d53-b127-f815859fada6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Substance
WARFARIN SODIUM
Active strength
10 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

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-4543-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-4543-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-4543-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-4543-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-4543-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-4543-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63629-4543-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63629-4543-2fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63629-4543-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-4543-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-4543-286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-4543-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-4543-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-4543-2bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-4543-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-4543-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-4543-28dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-4543-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4543-3e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4543-2e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4543-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4543-39bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4543-29bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4543-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4543-3110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4543-2110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4543-1110d247fa046…a55b01930146…

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
A040301-001WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB1999-07-15
A040301-002WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB1999-07-15
A040301-003WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB1999-07-15
A040301-004WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15
A040301-005WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB1999-07-15
A040301-006WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB1999-07-15
A040301-007WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB1999-07-15
A040301-008WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB1999-07-15
A040301-009WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040301-001AB
A040301-002AB
A040301-003AB
A040301-004AB
A040301-005AB
A040301-006AB
A040301-007AB
A040301-008AB
A040301-009AB

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 06:07:402026-07A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15fd3edfee7708…

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 06:07:402026-07A040301-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004AB1fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM10 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
855296Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
694e258d-86bd-440c-870b-a7d27fb1c467Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4543-12024-05-21These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
63629-4543-22024-05-21These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
63629-4543-32024-05-21These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
63629-4543-12019-11-27These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
63629-4543-22019-11-27These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954
63629-4543-32019-11-27These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4543-1Warfarin Sodium30 in 1 BOTTLETABLET301003
63629-4543-2Warfarin Sodium60 in 1 BOTTLETABLET601003
63629-4543-3Warfarin Sodium90 in 1 BOTTLETABLET901003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4543WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1002Current NDC, Legacy NDC, 3 package rows20240523_694e258d-86bd-440c-870b-a7d27fb1c467.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions8cd0e744-b499-4344-b1db-59f85950e1692026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions991b1e3e-236e-44cf-ad61-7233f777ce672026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.6b227c9e-02e9-4ec9-8b11-3ab6fe5093e52026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.72d3ea20-27e4-4368-a666-a9b76530dbb92026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.61ab23a7-bc67-4777-854a-bf43c788a69a2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.7b3b6f89-1feb-4939-a95b-7ad0707f4d762026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.73b8e5ab-86f8-44f8-b290-346acb81c9ae2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLCcdbbc317-35d3-42ba-94f0-c838913585292025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack694e258d-86bd-440c-870b-a7d27fb1c4672025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 63629-4543
Warfarin SodiumWARFARIN SODIUMGolden State Medical Supply, Inc.ba8b4ead-d080-91e7-e053-2995a90a82fe2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMSun Pharmaceutical Industries, Inc.8ad881e0-ca41-42ad-9d7d-eb85b3a30af02025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingab047628-67d0-4a64-8d77-36b054969b442024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingfeaa5f6f-9753-4f37-ab81-04c9c6b45e6a2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLCe73d37f8-8a28-4d93-9529-fd1e2c84228a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLC2c8f47c6-a180-4ad8-b962-04069d2270cb2021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855296warfarin sodium 10 MG Oral TabletPSN694e258d-86bd-440c-870b-a7d27fb1c4671003
855296warfarin sodium 10 MG Oral TabletSCD694e258d-86bd-440c-870b-a7d27fb1c4671003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4543-16362945430130 TABLET in 1 BOTTLE (63629-4543-1) 30 tablet2011-07-22NoNoCurrent
63629-4543-26362945430260 TABLET in 1 BOTTLE (63629-4543-2) 60 tablet2024-05-21NoNoCurrent
63629-4543-36362945430390 TABLET in 1 BOTTLE (63629-4543-3) 90 tablet2013-01-22NoNoCurrent