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
67dbca4d-1aea-48f8-a013-c14d5dc75f50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2022
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
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 Code66689-105
Application NumberNDA214047
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 5 mL
Code: 9J765S329G
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT