LEVOXYL
These highlights do not include all the information needed to use LEVOXYL safely and effectively. See full prescribing information for LEVOXYL. LEVOXYL (levothyroxine sodium) tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
758588c3-c63e-491b-0aa2-4f50d80cb174
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2020
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-852
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-853
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 88 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-854
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-860
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 200 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-859
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-855
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 112 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-856
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 125 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-858
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 150 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-857
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 137 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60793-850
Application NumberNDA021301
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2020
FDA Product Classification
INGREDIENTS (3)
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 1
Code: 9J765S329G
Classification: ACTIR