Methimazole
Methimazole Tablets USP
Approved
Approval ID
39159f2f-7291-40cc-b688-14f10104ac10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 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 Code63629-2224
Application NumberANDA040350
Product Classification
M
Marketing Category
C73584
G
Generic Name
methimazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHIMAZOLEActive
Quantity: 10 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 8/19/2016
CONTRAINDICATIONS
Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 8/19/2016
HOW SUPPLIED
NDC: 63629-2224-1: 100 Tablets in a BOTTLE