Methimazole
Methimazole Tablets, USP Rx only
Approved
Approval ID
d003a93d-da08-4993-bb72-700342ca6e65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9251
Application NumberANDA040350
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (5)
METHIMAZOLEActive
Quantity: 10 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT