Home NDC 67046-2072 Warfarin Sodium
Product NDC 67046-2072
11-digit product format 670462072
Labeler code 67046
Product ID 67046-2072_52bac5dc-e9f1-728d-e063-6394a90a2f1c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA202202
Marketing category ANDA
Marketing start 2026-05-26
Substance WARFARIN SODIUM
Active strength 1 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202202-001 WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 A202202-002 WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 A202202-003 WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 A202202-004 WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 A202202-005 WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 A202202-006 WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 A202202-007 WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 A202202-008 WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 A202202-009 WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04
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 · 387 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 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202202-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202202-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202202-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202202-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 387 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Warfarin Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WARFARIN SODIUM 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6153CWM0CL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855288 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67046-2072-3 Warfarin Sodium 30 in 1 BLISTER PACK TABLET 30 1
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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67046-2072-3 67046207203 30 TABLET in 1 BLISTER PACK (67046-2072-3) 30 tablet 2026-05-26 No No Current