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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

4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2019

Manufacturers
FDA

MAIA Pharmaceuticals, Inc.

DUNS: 079211845

Products 3

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 Code70511-112
Application NumberANDA208749
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM ANHYDROUS
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2019
FDA Product Classification

INGREDIENTS (4)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LEVOTHYROXINE SODIUM ANHYDROUSActive
Quantity: 200 ug in 5 mL
Code: 054I36CPMN
Classification: ACTIB

LEVOTHYROXINE SODIUM ANHYDROUS

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70511-111
Application NumberANDA208749
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM ANHYDROUS
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 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 Code70511-113
Application NumberANDA208749
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM ANHYDROUS
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2019
FDA Product Classification

INGREDIENTS (4)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LEVOTHYROXINE SODIUM ANHYDROUSActive
Quantity: 500 ug in 5 mL
Code: 054I36CPMN
Classification: ACTIB

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Levothyroxine Sodium - FDA Drug Approval Details