methotrexate

Generic: methotrexate sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
Active Ingredients

methotrexate sodium 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-122
Product ID 63323-122_3d21237a-ef53-4592-bf06-0c739696203d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040266
Listing Expiration 2026-12-31
Marketing Start 2000-01-22

Pharmacologic Class

Classes
folate analog metabolic inhibitor [epc] folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323122
Hyphenated Format 63323-122

Supplemental Identifiers

RxCUI
311625
UNII
3IG1E710ZN

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methotrexate (source: ndc)
Generic Name methotrexate sodium (source: ndc)
Application Number ANDA040266 (source: ndc)
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

63323-122-50 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

methotrexate sodium (1 g/1)

Linked Drug Pages (1)

Methotrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS"], "spl_id": "3d21237a-ef53-4592-bf06-0c739696203d", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["311625"], "spl_set_id": ["ec476b11-0b3c-4139-b1eb-a3daa76bc271"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-122-50)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "63323-122-50", "marketing_start_date": "20000122"}], "brand_name": "Methotrexate", "product_id": "63323-122_3d21237a-ef53-4592-bf06-0c739696203d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "63323-122", "generic_name": "METHOTREXATE SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "1 g/1"}], "application_number": "ANDA040266", "marketing_category": "ANDA", "marketing_start_date": "20000122", "listing_expiration_date": "20261231"}