Warfarin Sodium
These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954
Approved
Approval ID
b1b766b1-0327-48cd-ab01-e85038cf365f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2012
Manufacturers
FDA
Med-Health Pharma, LLC
DUNS: 962603812
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 Code51138-057
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (8)
Warfarin SodiumActive
Quantity: 3 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-060
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (7)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Warfarin SodiumActive
Quantity: 6 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-054
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (6)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin SodiumActive
Quantity: 1 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
D&C Red No. 6Inactive
Code: 481744AI4O
Classification: IACT
Barium OxideInactive
Code: 77603K202B
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-055
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (6)
Warfarin SodiumActive
Quantity: 2 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-059
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (8)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin SodiumActive
Quantity: 5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
D&C Red No. 6Inactive
Code: 481744AI4O
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Barium OxideInactive
Code: 77603K202B
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-061
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (6)
Warfarin SodiumActive
Quantity: 7.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-056
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (7)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Warfarin SodiumActive
Quantity: 2.5 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
warfarin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-062
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (4)
Warfarin SodiumActive
Quantity: 10 mg in 1 1
Code: 6153CWM0CL
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
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 Code51138-058
Application NumberANDA040301
Product Classification
M
Marketing Category
C73584
G
Generic Name
warfarin sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2011
FDA Product Classification
INGREDIENTS (6)
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Warfarin SodiumActive
Quantity: 4 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
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT