Levothyroxine Sodium
Levothyroxine Sodium Tablets, USP
Approved
Approval ID
bebe7897-2ee4-4aa1-b499-5b822bd03971
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
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 Code52959-920
Application NumberNDA021210
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (12)
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Levothyroxine SodiumActive
Quantity: 0.125 mg in 1 1
Code: 9J765S329G
Classification: ACTIM
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-089
Application NumberNDA021210
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (11)
Levothyroxine SodiumActive
Quantity: 0.1 mg in 1 1
Code: 9J765S329G
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT