Methimazole
METHIMAZOLE TABLETS, USP
Approved
Approval ID
68942ec1-763a-4757-96ad-0e749aba348c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2020
Manufacturers
FDA
ECI Pharmaceuticals, LLC
DUNS: 962476029
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 Code51293-820
Application NumberANDA040547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2017
FDA Product Classification
INGREDIENTS (5)
METHIMAZOLEActive
Quantity: 5 mg in 1 1
Code: 554Z48XN5E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
Methimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-821
Application NumberANDA040547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methimazole
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2017
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, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT