Warfarin Sodium
WARFARIN SODIUM TABLETS, USP
Approved
Approval ID
3fb2aa58-3a40-4255-a261-e2db5b9a5dde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-058
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (8)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
WARFARIN SODIUMActive
Quantity: 7.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-059
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (5)
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-057
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (8)
WARFARIN SODIUMActive
Quantity: 6 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
FD&C BLUE NO. 1--ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-054
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (9)
WARFARIN SODIUMActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-053
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 2 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-056
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-052
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 1 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 6 BARIUM LAKEInactive
Code: K4XZD9W99K
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-064
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (8)
WARFARIN SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1--ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-055
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 4 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1--ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT