Home NDC 65162-769 Warfarin Sodium
Product NDC 65162-769
11-digit product format 651620769
Labeler code 65162
Product ID 65162-769_caa13d7d-5a78-412c-8e5e-e03a51164e96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA202202
Marketing category ANDA
Marketing start 2010-08-16
Substance WARFARIN SODIUM
Active strength 10 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 10 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 · 9 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855288 Internal RxNorm lookup 855296 Internal RxNorm lookup 855302 Internal RxNorm lookup 855312 Internal RxNorm lookup 855318 Internal RxNorm lookup 855324 Internal RxNorm lookup 855332 Internal RxNorm lookup 855338 Internal RxNorm lookup 855344 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 65162-769-10 Warfarin Sodium 100 in 1 BOTTLE TABLET 100 19 65162-769-11 Warfarin Sodium 1000 in 1 BOTTLE TABLET 1000 19 65162-769-50 Warfarin Sodium 500 in 1 BOTTLE TABLET 500 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded WARFARIN SODIUM ACTIVE INGREDIENT 6153CWM0CL WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 WARFARIN ACTIVE MOIETY 5Q7ZVV76EI WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 D&C RED NO. 6 INACTIVE INGREDIENT 481744AI4O WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 HYDROXYPROPYL CELLULOSE (TYPE E) INACTIVE INGREDIENT 66O7AQV0RT WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-769 WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS LLC] 19 Current NDC, Legacy NDC, 3 package rows 20241031_558b7a0d-5490-4c1b-802e-3ab3f1efe760.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 65162-769-10 65162076910 100 TABLET in 1 BOTTLE (65162-769-10) 100 tablet 2010-08-16 0000-00-00 No No Current 65162-769-11 65162076911 1000 TABLET in 1 BOTTLE (65162-769-11) 1000 tablet 2010-08-16 0000-00-00 No No Current 65162-769-50 65162076950 500 TABLET in 1 BOTTLE (65162-769-50) 500 tablet 2010-08-16 0000-00-00 No No Current