Methotrexate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953
Approved
Approval ID
223fde57-7b13-4fd7-90e2-f74fc0846431
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2021
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
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 Code0703-3678
Application NumberANDA040843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 25 mg in 1 mL
Code: 3IG1E710ZN
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT