Methimazole
Methimazole Tablets, USP
Approved
Approval ID
5b25e346-11b6-44ed-89f9-ab927232ac19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2022
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-206
Application NumberANDA040411
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHIMAZOLEActive
Quantity: 10 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Methimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-205
Application NumberANDA040411
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHIMAZOLEActive
Quantity: 5 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT