Methotrexate
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
Approved
Approval ID
dd39255b-81d1-4c08-aecf-acc4f2cdc04a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2022
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1423
Application NumberANDA210040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (4)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT