Methotrexate
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953
Approved
Approval ID
dd035a9f-cd40-4314-b9d8-2294b8a924e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 4, 2021
Manufacturers
FDA
Accord Healthcare, Inc.
DUNS: 604222237
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 Code16729-277
Application NumberANDA040716
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
Effective DateJune 4, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHOTREXATEActive
Quantity: 25 mg in 1 mL
Code: YL5FZ2Y5U1
Classification: ACTIB