Home NDC 0056-0168 COUMADIN
Product NDC 0056-0168
11-digit product format 000560168
Labeler code 0056
Product ID 0056-0168_4fa626bf-835e-4641-b783-bc1c8e3ad767
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name warfarin sodium
Dosage form TABLET
Route ORAL
Labeler Bristol-Myers Squibb Pharma Company
Application NDA009218
Marketing category NDA
Marketing start 2009-01-01
Marketing end 2020-12-31
Substance WARFARIN SODIUM
Active strength 4 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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1982 N009218-022 COUMADIN WARFARIN SODIUM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 N009218-023 COUMADIN WARFARIN SODIUM 4MG TABLET / ORAL RLD 1993-08-24 N009218-024 COUMADIN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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded warfarin sodium ACTIVE INGREDIENT 6153CWM0CL COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 warfarin ACTIVE MOIETY 5Q7ZVV76EI COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 barium sulfate INACTIVE INGREDIENT 25BB7EKE2E COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 D&C Red No. 6 INACTIVE INGREDIENT 481744AI4O COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 lactose INACTIVE INGREDIENT J2B2A4N98G COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 starch, tapioca INACTIVE INGREDIENT 24SC3U704I COUMADIN (WARFARIN SODIUM) TABLET [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 8 warfarin sodium ACTIVE INGREDIENT 6153CWM0CL COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 warfarin ACTIVE MOIETY 5Q7ZVV76EI COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 barium sulfate INACTIVE INGREDIENT 25BB7EKE2E COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 D&C Red No. 6 INACTIVE INGREDIENT 481744AI4O COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 lactose INACTIVE INGREDIENT J2B2A4N98G COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4 starch, tapioca INACTIVE INGREDIENT 24SC3U704I COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.] 4
DailyMed RxNorm Mappings#