Levothyroxine Sodium
These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM FOR INJECTION safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM FOR INJECTION. LEVOTHYROXINE SODIUM for injection, for intravenous use. Initial U.S. Approval: 1969
Approved
Approval ID
152d071f-d4aa-46d2-b397-61c1cabdd86d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2019
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LEVOTHYROXINE SODIUM ANHYDROUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-649
Application NumberNDA202231
Product Classification
M
Marketing Category
C73594
G
Generic Name
LEVOTHYROXINE SODIUM ANHYDROUS
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (4)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LEVOTHYROXINE SODIUM ANHYDROUSActive
Quantity: 100 ug in 5 mL
Code: 054I36CPMN
Classification: ACTIB
LEVOTHYROXINE SODIUM ANHYDROUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-648
Application NumberNDA202231
Product Classification
M
Marketing Category
C73594
G
Generic Name
LEVOTHYROXINE SODIUM ANHYDROUS
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LEVOTHYROXINE SODIUM ANHYDROUSActive
Quantity: 500 ug in 5 mL
Code: 054I36CPMN
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT