LEVOTHYROXINE SODIUM
These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral useInitial U.S. Approval: 2002
Approved
Approval ID
03e3d1fe-108f-46ee-8b6a-b5cebaaa3c42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Ascent Pharmaceuticals, Inc
DUNS: 080938961
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 Code43602-424
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (8)
LEVOTHYROXINE SODIUMActive
Quantity: 0.137 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-425
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (8)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.15 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-419
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (9)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.075 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-418
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (7)
LEVOTHYROXINE SODIUMActive
Quantity: 0.05 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-421
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (9)
LEVOTHYROXINE SODIUMActive
Quantity: 0.1 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-420
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
LEVOTHYROXINE SODIUMActive
Quantity: 0.088 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-428
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (9)
LEVOTHYROXINE SODIUMActive
Quantity: 0.3 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-427
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (8)
LEVOTHYROXINE SODIUMActive
Quantity: 0.2 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-417
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (8)
LEVOTHYROXINE SODIUMActive
Quantity: 0.025 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-423
Application NumberANDA215259
Product Classification
M
Marketing Category
C73584
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.125 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT