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
7a7aa8d3-6b18-fe49-e053-2991aa0ae384
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2019
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4625
Application NumberNDA021342
Product Classification
M
Marketing Category
C73605
G
Generic Name
Levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2019
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIR