Adthyza Thyroid
ADTHYZA (thyroid tablets, USP)
Approved
Approval ID
7d867bc5-3e7a-4346-8129-31c3b9d8b40a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levothyroxine and Liothyronine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-006
Product Classification
G
Generic Name
Levothyroxine and Liothyronine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
LevothyroxineActive
Quantity: 19 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
LiothyronineActive
Quantity: 4.5 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Levothyroxine and Liothyronine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-009
Product Classification
G
Generic Name
Levothyroxine and Liothyronine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
LevothyroxineActive
Quantity: 76 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
LiothyronineActive
Quantity: 18 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
Levothyroxine and Liothyronine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-008
Product Classification
G
Generic Name
Levothyroxine and Liothyronine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LevothyroxineActive
Quantity: 57 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
LiothyronineActive
Quantity: 13.5 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
Levothyroxine and Liothyronine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-007
Product Classification
G
Generic Name
Levothyroxine and Liothyronine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LevothyroxineActive
Quantity: 38 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
LiothyronineActive
Quantity: 9 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
Levothyroxine and Liothyronine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-005
Product Classification
G
Generic Name
Levothyroxine and Liothyronine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (8)
LevothyroxineActive
Quantity: 9.5 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
LiothyronineActive
Quantity: 2.25 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT