Home NDC 63629-3177-4 Warfarin Sodium
Product NDC 63629-3177
Requested package NDC 63629-3177-4
11-digit product format 636293177
Labeler code 63629
Product ID 63629-3177_7e8a3a4e-87e5-43af-b041-df00b4c95fc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin Sodium
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040663
Marketing category ANDA
Marketing start 2006-06-19
Marketing end 0000-00-00
Substance WARFARIN SODIUM
Active strength 3 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040663-001 WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 A040663-002 WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 A040663-003 WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 A040663-004 WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 A040663-005 WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 A040663-006 WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 A040663-007 WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 A040663-008 WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 A040663-009 WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 9 matching rows.
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 a50c72e98297…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 63629-3177-1 2020-10-12 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-2 2020-10-12 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-3 2020-10-12 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-4 2020-10-12 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-5 2020-10-12 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-1 2020-01-31 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-2 2020-01-31 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-3 2020-01-31 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-4 2020-01-31 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954 63629-3177-5 2020-01-31 C162847 48780-1 9d75b9cf-fec9-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets, USP Initial U.S. Approval: 1954
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-3177-4 63629317704 90 TABLET in 1 BOTTLE (63629-3177-4) 90 tablet 2006-06-19 0000-00-00 No No Current