Home DailyMed 5c1933c8-6e8e-41ff-836c-fe46351016ee National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:52:38
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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1982 N009218-022 COUMADIN WARFARIN SODIUM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1990-03-01 N009218-023 COUMADIN WARFARIN SODIUM 4MG TABLET / ORAL RLD 1993-08-24 N009218-024 COUMADIN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 · 516 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 2026-09-14 22:38:34 2026-08 N009218-005 COUMADIN 10MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-007 COUMADIN 5MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-012 COUMADIN 75MG/VIAL INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-013 COUMADIN 2MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-016 COUMADIN 7.5MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-018 COUMADIN 2.5MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-020 COUMADIN 50MG/VIAL INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-023 COUMADIN 4MG TABLET / ORAL RLD 1993-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-024 COUMADIN 5MG/VIAL INJECTABLE / INJECTION 1995-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-025 COUMADIN 3MG TABLET / ORAL RLD 1996-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N009218-026 COUMADIN 6MG TABLET / ORAL RLD 1996-11-18 84e616aacf4f…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.