Methimazole
Rx only
Approved
Approval ID
381052c4-891c-4ae4-b63e-65229126cbca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 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 Code71335-0883
Application NumberANDA040734
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 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