Home NDC 50090-2582 Warfarin Sodium
Product NDC 50090-2582
11-digit product format 500902582
Labeler code 50090
Product ID 50090-2582_af41a188-068e-42ec-bb07-e921815b791e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA202202
Marketing category ANDA
Marketing start 2010-08-16
Substance WARFARIN SODIUM
Active strength 7.5 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 50090-2582 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50090-2582 50090-2582-0 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 396 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 2026-10-15 13:18:30 2026-09 A202202-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202202-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2013-03-04 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 396 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 7.5 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-2582-0 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-0 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-0 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-12-15 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-0 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-0 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-0 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954 50090-2582-1 2020-01-31 These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2582-0 Warfarin Sodium 30 in 1 BOTTLE TABLET 30 51 50090-2582-1 Warfarin Sodium 90 in 1 BOTTLE TABLET 90 51
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2582 WARFARIN SODIUM (WARFARIN) TABLET [A-S MEDICATION SOLUTIONS] 51 Current NDC, Legacy NDC, 2 package rows 20250410_541c9a70-adaf-4ef3-94ba-ad4e70dfa057.zip
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 Marketing end Sample Exclude flag Status 50090-2582-0 50090258200 30 TABLET in 1 BOTTLE (50090-2582-0) 30 tablet 2016-11-01 0000-00-00 No No Current 50090-2582-1 50090258201 90 TABLET in 1 BOTTLE (50090-2582-1) 90 tablet 2017-01-11 0000-00-00 No No Current