Home NDC 68788-8402 Warfarin Sodium
Product NDC 68788-8402
11-digit product format 687888402
Labeler code 68788
Product ID 68788-8402_3687ceaf-725c-4aea-9708-af212aacf43e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA202202
Marketing category ANDA
Marketing start 2023-03-21
Substance WARFARIN SODIUM
Active strength 2.5 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WARFARIN SODIUM 2.5 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 855312 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 68788-8402-1 Warfarin Sodium 100 in 1 BOTTLE TABLET 100 2 68788-8402-3 Warfarin Sodium 30 in 1 BOTTLE TABLET 30 2 68788-8402-6 Warfarin Sodium 60 in 1 BOTTLE TABLET 60 2 68788-8402-9 Warfarin Sodium 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8402 WARFARIN SODIUM (WARFARIN) TABLET [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 4 package rows 20250119_ac117f50-8e67-4203-8d97-e53dd0687c20.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 Sample Exclude flag Status 68788-8402-1 68788840201 100 TABLET in 1 BOTTLE (68788-8402-1) 100 tablet 2023-03-21 No No Current 68788-8402-3 68788840203 30 TABLET in 1 BOTTLE (68788-8402-3) 30 tablet 2023-03-21 No No Current 68788-8402-6 68788840206 60 TABLET in 1 BOTTLE (68788-8402-6) 60 tablet 2023-03-21 No No Current 68788-8402-9 68788840209 90 TABLET in 1 BOTTLE (68788-8402-9) 90 tablet 2023-03-21 No No Current