Liothyronine Sodium
These highlights do not include all the information needed to use LIOTHYRONINE SODIUM TABLETS, USP safely and effectively. See full prescribing information for LIOTHYRONINE SODIUM TABLETS, USP. LIOTHYRONINE SODIUM TABLETS, USP, for oral use Initial U.S. Approval: 1956
Approved
Approval ID
38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
SIGMAPHARM LABORATORIES, LLC
DUNS: 556234636
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Liothyronine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-019
Application NumberANDA200295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Liothyronine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LIOTHYRONINE SODIUMActive
Quantity: 25 ug in 1 1
Code: GCA9VV7D2N
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Liothyronine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-020
Application NumberANDA200295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Liothyronine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (1)
LIOTHYRONINE SODIUMActive
Quantity: 50 ug in 1 1
Code: GCA9VV7D2N
Classification: ACTIM
Liothyronine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-018
Application NumberANDA200295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Liothyronine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LIOTHYRONINE SODIUMActive
Quantity: 5 ug in 1 1
Code: GCA9VV7D2N
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT