Methimazole
Methimazole Tablets, USP Rx only
Approved
Approval ID
289ec852-176e-41aa-9f9a-b1f9b4196771
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 2
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 Code64980-265
Application NumberANDA202068
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (4)
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
methimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-264
Application NumberANDA202068
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (4)
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