Methimazole
Rx only
Approved
Approval ID
c1e6f1ee-238c-466e-b223-3c3f63dac9ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8226
Application NumberANDA040734
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (5)
METHIMAZOLEActive
Quantity: 5 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