Methimazole
Approved
Approval ID
74238d87-5f82-4a5e-a920-a9fc68115e91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2011
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code42254-008
Application NumberANDA040350
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (5)
METHIMAZOLEActive
Quantity: 5 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
methimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-009
Application NumberANDA040350
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (5)
METHIMAZOLEActive
Quantity: 10 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT