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
eb120047-a43b-40a4-9f55-067b1b51edda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 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
NDC Product Code50090-6880
Application NumberANDA209713
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 8, 2023
Generic NameLevothyroxine Sodium
INGREDIENTS (7)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 0.112 mg in 1 1
Code: 9J765S329G
Classification: ACTIR