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
7f8ec438-8ddf-45d2-be94-ac032e192229
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-4951
Application NumberANDA209713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (9)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.088 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT