Levothyroxine Sodium
Levothyroxine Sodium Tablets, USP
Approved
Approval ID
46a9e4e6-af7f-4f60-a888-c6d3afce8113
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2017
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
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 Code68788-9161
Application NumberNDA021210
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2017
FDA Product Classification
INGREDIENTS (8)
LEVOTHYROXINE SODIUMActive
Quantity: 0.05 mg in 1 1
Code: 9J765S329G
Classification: ACTIR
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT