Home NDC 43353-494 COUMADIN
Product NDC 43353-494
11-digit product format 433530494
Labeler code 43353
Product ID 43353-494_6e052f18-f7a6-4e8b-9222-0a12572960b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name warfarin sodium
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, Inc.
Application NDA009218
Marketing category NDA
Marketing start 2009-01-01
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 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 · 42 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 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 43353-494-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-494-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-494-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-494-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-494-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-494-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-494-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-494-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-494-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-494-30 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 12 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N009218-005 COUMADIN WARFARIN SODIUM 10MG TABLET / ORAL RLD, Approved before 1982 N009218-007 COUMADIN WARFARIN SODIUM 5MG TABLET / ORAL RLD, Approved before 1982 N009218-012 COUMADIN WARFARIN SODIUM 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 N009218-013 COUMADIN WARFARIN SODIUM 2MG TABLET / ORAL RLD, Approved before 1982 N009218-016 COUMADIN WARFARIN SODIUM 7.5MG TABLET / ORAL RLD, Approved before 1982 N009218-018 COUMADIN WARFARIN SODIUM 2.5MG TABLET / ORAL RLD, Approved before 1982 N009218-020 COUMADIN WARFARIN SODIUM 50MG/VIAL INJECTABLE / INJECTION Approved before 1982 N009218-022 COUMADIN WARFARIN SODIUM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 N009218-023 COUMADIN WARFARIN SODIUM 4MG TABLET / ORAL RLD 1993-08-24 N009218-024 COUMADIN WARFARIN SODIUM 5MG/VIAL INJECTABLE / INJECTION 1995-02-07 N009218-025 COUMADIN WARFARIN SODIUM 3MG TABLET / ORAL RLD 1996-11-18 N009218-026 COUMADIN WARFARIN SODIUM 6MG TABLET / ORAL RLD 1996-11-18
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 13 · 504 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 N009218-005 COUMADIN 10MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-007 COUMADIN 5MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-012 COUMADIN 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-013 COUMADIN 2MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-016 COUMADIN 7.5MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-018 COUMADIN 2.5MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-020 COUMADIN 50MG/VIAL INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-022 COUMADIN 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-023 COUMADIN 4MG TABLET / ORAL RLD 1993-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-024 COUMADIN 5MG/VIAL INJECTABLE / INJECTION 1995-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-025 COUMADIN 3MG TABLET / ORAL RLD 1996-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N009218-026 COUMADIN 6MG TABLET / ORAL RLD 1996-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N009218-005 COUMADIN 10MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-007 COUMADIN 5MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-012 COUMADIN 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-013 COUMADIN 2MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-016 COUMADIN 7.5MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-018 COUMADIN 2.5MG TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-020 COUMADIN 50MG/VIAL INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-022 COUMADIN 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-023 COUMADIN 4MG TABLET / ORAL RLD 1993-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-024 COUMADIN 5MG/VIAL INJECTABLE / INJECTION 1995-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-025 COUMADIN 3MG TABLET / ORAL RLD 1996-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N009218-026 COUMADIN 6MG TABLET / ORAL RLD 1996-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-005 COUMADIN 10MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-007 COUMADIN 5MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-012 COUMADIN 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-013 COUMADIN 2MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-016 COUMADIN 7.5MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-018 COUMADIN 2.5MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-020 COUMADIN 50MG/VIAL INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-022 COUMADIN 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-023 COUMADIN 4MG TABLET / ORAL RLD 1993-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-024 COUMADIN 5MG/VIAL INJECTABLE / INJECTION 1995-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-025 COUMADIN 3MG TABLET / ORAL RLD 1996-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N009218-026 COUMADIN 6MG TABLET / ORAL RLD 1996-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N009218-005 COUMADIN 10MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N009218-007 COUMADIN 5MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N009218-012 COUMADIN 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N009218-013 COUMADIN 2MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-494-30 COUMADIN 30 in 1 BOTTLE, PLASTIC TABLET 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded warfarin sodium ACTIVE INGREDIENT 6153CWM0CL COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 warfarin ACTIVE MOIETY 5Q7ZVV76EI COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 barium sulfate INACTIVE INGREDIENT 25BB7EKE2E COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 D&C Red No. 6 INACTIVE INGREDIENT 481744AI4O COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 lactose INACTIVE INGREDIENT J2B2A4N98G COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 starch, tapioca INACTIVE INGREDIENT 24SC3U704I COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-494 COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 Legacy NDC, 1 package rows 20120815_ba41b963-ec4a-4421-ac93-26654876a6be.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-494-30 43353049430 30 in 1 BOTTLE, PLASTIC Historical