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 use Initial U.S. Approval: 2002
Approved
Approval ID
73c3d459-dcbf-4458-8edd-2637275a96a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2094
Application NumberNDA021342
Product Classification
M
Marketing Category
C73605
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 23, 2020
FDA Product Classification
INGREDIENTS (8)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 300 ug in 1 1
Code: 9J765S329G
Classification: ACTIR