Home NDC 68382-053 Warfarin Sodium
Product NDC 68382-053
11-digit product format 683820053
Labeler code 68382
Product ID 68382-053_5bff866a-04d9-4326-83d3-4e9607b2e860
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Warfarin Sodium
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA040663
Marketing category ANDA
Marketing start 2006-06-19
Marketing end 0000-00-00
Substance WARFARIN SODIUM
Active strength 2 mg/1
Pharmacologic classes Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040663-001 WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 A040663-002 WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 A040663-003 WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 A040663-004 WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 A040663-005 WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 A040663-006 WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 A040663-007 WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 A040663-008 WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 A040663-009 WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30
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.
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 2026-08-01 22:54:32 2026-06 A040663-001 WARFARIN SODIUM 1MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-002 WARFARIN SODIUM 2MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-003 WARFARIN SODIUM 2.5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-004 WARFARIN SODIUM 3MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-005 WARFARIN SODIUM 4MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-006 WARFARIN SODIUM 5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-007 WARFARIN SODIUM 6MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-008 WARFARIN SODIUM 7.5MG TABLET / ORAL AB 2006-05-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A040663-009 WARFARIN SODIUM 10MG TABLET / ORAL AB 2006-05-30 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded WARFARIN SODIUM ACTIVE INGREDIENT 6153CWM0CL WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 WARFARIN ACTIVE MOIETY 5Q7ZVV76EI WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 D&C RED NO. 6 INACTIVE INGREDIENT 481744AI4O WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 9 WARFARIN SODIUM ACTIVE INGREDIENT 6153CWM0CL WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 WARFARIN ACTIVE MOIETY 5Q7ZVV76EI WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 D&C RED NO. 6 INACTIVE INGREDIENT 481744AI4O WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ WARFARIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 3 WARFARIN SODIUM ACTIVE INGREDIENT 6153CWM0CL WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 WARFARIN SODIUM ACTIVE INGREDIENT 6153CWM0CL WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 WARFARIN ACTIVE MOIETY 5Q7ZVV76EI WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 WARFARIN ACTIVE MOIETY 5Q7ZVV76EI WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 D&C RED NO. 6 INACTIVE INGREDIENT 481744AI4O WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ WARFARIN SODIUM TABLET [UNIT DOSE SERVICES] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ WARFARIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-053 WARFARIN SODIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.] 11 Legacy NDC 20221115_e9d8fb69-a4c7-48cb-a4a9-e5d18eb4fd63.zip
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 68382-053-01 68382005301 100 TABLET in 1 BOTTLE (68382-053-01) 100 tablet 2006-06-19 0000-00-00 No No Current 68382-053-10 68382005310 1000 TABLET in 1 BOTTLE (68382-053-10) 1000 tablet 2006-06-19 0000-00-00 No No Current