Home NDC 65841-058 Warfarin Sodium
Product NDC 65841-058
11-digit product format 658410058
Labeler code 65841
Product ID 65841-058_d574b623-3aee-4c1f-b85b-e9e51d388286
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin Sodium
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA040663
Marketing category ANDA
Marketing start 2006-06-19
Marketing end 0000-00-00
Substance WARFARIN SODIUM
Active strength 8 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65841-058-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65841-058-01 f5e01cc5f278…a2eaf40c39c3…
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-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.
Product history page 1 of 10 · 378 observed 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 2026-08-18 06:07:40 2026-07 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 378 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-058 WARFARIN SODIUM TABLET [ZYDUS LIFESCIENCES LIMITED] 8 Legacy NDC 20231005_3fb2aa58-3a40-4255-a261-e2db5b9a5dde.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65841-058-01 65841005801 100 TABLET in 1 BOTTLE (65841-058-01) 100 tablet 2006-06-19 0000-00-00 No No Current