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
8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
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 Code51079-670
Application NumberANDA081235
Product Classification
M
Marketing Category
C73584
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 2.5 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM