THYQUIDITY
These highlights do not include all the information needed to use safely and effectively. (levothyroxine sodium) oral solution Initial U.S. Approval: 2000
Approved
Approval ID
c17ec992-a122-4cd9-8469-d91255c32440
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
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 Code52652-1950
Application NumberNDA214047
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 5 mL
Code: 9J765S329G
Classification: ACTIR
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT