Warfarin Sodium
Warfarin Sodium Tablets, USP
Approved
Approval ID
36a919ce-7a21-40c0-9af5-2299bf2b1f97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 8
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 Code21695-672
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 1 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
D&C RED NO. 6Inactive
Code: 481744AI4O
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
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 Code21695-940
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-673
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 2 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
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 Code21695-677
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (6)
WARFARIN SODIUMActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-674
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (7)
WARFARIN SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-675
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (8)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
WARFARIN SODIUMActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-939
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Warfarin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-801
Application NumberANDA040663
Product Classification
M
Marketing Category
C73584
G
Generic Name
Warfarin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2008
FDA Product Classification
INGREDIENTS (5)
WARFARIN SODIUMActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT