Synthroid
SYNTHROID®(levothyroxine sodium tablets, USP)
Approved
Approval ID
00eea4aa-f08e-419a-827a-56e40e93f05f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-591
Application NumberNDA021402
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2013
FDA Product Classification
INGREDIENTS (7)
LEVOTHYROXINEActive
Quantity: 150 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT