Home NDC 55154-5619 Jantoven
Product NDC 55154-5619
11-digit product format 551545619
Labeler code 55154
Product ID 55154-5619_c36f8148-65c6-4008-9e9d-547d3e43daa7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin Sodium
Dosage form TABLET
Route ORAL
Labeler Cardinal Health
Application ANDA040416
Marketing category ANDA
Marketing start 2010-02-23
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 2019-12-31
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 · 24 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 55154-5619-0 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 55154-5619-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55154-5619-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55154-5619-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55154-5619-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55154-5619-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55154-5619-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55154-5619-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55154-5619-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55154-5619-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55154-5619-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55154-5619-0 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040416-001 JANTOVEN WARFARIN SODIUM 1MG TABLET / ORAL AB 2003-10-02 A040416-002 JANTOVEN WARFARIN SODIUM 2MG TABLET / ORAL AB 2003-10-02 A040416-003 JANTOVEN WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2003-10-02 A040416-004 JANTOVEN WARFARIN SODIUM 3MG TABLET / ORAL AB 2003-10-02 A040416-005 JANTOVEN WARFARIN SODIUM 4MG TABLET / ORAL AB 2003-10-02 A040416-006 JANTOVEN WARFARIN SODIUM 5MG TABLET / ORAL AB 2003-10-02 A040416-007 JANTOVEN WARFARIN SODIUM 6MG TABLET / ORAL AB 2003-10-02 A040416-008 JANTOVEN WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2003-10-02 A040416-009 JANTOVEN WARFARIN SODIUM 10MG TABLET / ORAL AB 2003-10-02
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 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-005 JANTOVEN 4MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-006 JANTOVEN 5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-007 JANTOVEN 6MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-008 JANTOVEN 7.5MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040416-009 JANTOVEN 10MG TABLET / ORAL AB 2003-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-001 JANTOVEN 1MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-002 JANTOVEN 2MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-003 JANTOVEN 2.5MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040416-004 JANTOVEN 3MG TABLET / ORAL AB 2003-10-02 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 378 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Jantoven WARFARIN SODIUM Upsher-Smith Laboratories, LLC 19a69a72-ac5d-45d5-a94d-a5aaecbe4730 2025-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040416 application number: ANDA040416