WARFARIN SODIUM

Product NDC
61919-341
11-digit product format
619190341
Labeler code
61919
Product ID
61919-341_3e6c2449-48b0-4cc4-81c3-2abd8dfabb59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WARFARIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-341IInactivated by FDA2026-10-05
excluded packagepackage61919-34161919-341-30IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-341-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-341-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-341-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-341-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-341-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-341-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-341-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-341-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-341-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-341-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-341-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-341-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-341-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-341-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-341-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-341-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-341-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-341-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-341-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-341-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-341-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-341-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-0584e616aacf4f…
2026-09-14 22:38:342026-08A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A040616-001WARFARIN SODIUM2MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-002WARFARIN SODIUM2.5MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-003WARFARIN SODIUM3MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-004WARFARIN SODIUM4MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-005WARFARIN SODIUM5MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-006WARFARIN SODIUM6MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-007WARFARIN SODIUM7.5MGTABLET / ORALAB2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-008WARFARIN SODIUM10MGTABLET / ORALABRS2006-07-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-009WARFARIN SODIUM1MGTABLET / ORALAB2006-07-05caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040616-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-008AB184e616aacf4f…
2026-09-14 22:38:342026-08A040616-009AB184e616aacf4f…
2026-08-18 06:07:402026-07A040616-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040616-009AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-341-302020-01-31C16284748780-19d75b9d0-d1ad-f424-e053-dadaa90a57ceWARFARIN SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-341-30WARFARIN SODIUM30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-341-30EA - Each61919-341dcf25da1-7cd9-4114-9c2a-8fdaed9cbca212017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [DIRECTRX]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [DIRECTRX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWARFARIN SODIUM TABLET [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WARFARIN SODIUM TABLET [DIRECTRX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [DIRECTRX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [DIRECTRX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WARFARIN SODIUM TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-341WARFARIN SODIUM TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151029_bf21781b-d4d5-456d-a5bc-d48bd2da61ce.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 TabletPSNbf21781b-d4d5-456d-a5bc-d48bd2da61ce1
855332warfarin sodium 5 MG Oral TabletSCDbf21781b-d4d5-456d-a5bc-d48bd2da61ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-341-306191903413030 in 1 BOTTLEHistorical