methotrexate

Generic: methotrexate

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

methotrexate sodium 25 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 61703-161
Product ID 61703-161_6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA011719
Listing Expiration 2026-12-31
Marketing Start 2024-11-04

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 61703161
Hyphenated Format 61703-161

Supplemental Identifiers

RxCUI
1655956 1946772
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 (source: ndc)
Application Number NDA011719 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 CARTON (61703-161-05) / 2 mL in 1 VIAL, MULTI-DOSE (61703-161-02)
source: ndc

Packages (1)

61703-161-05 5 VIAL, MULTI-DOSE in 1 CARTON (61703-161-05) / 2 mL in 1 VIAL, MULTI-DOSE (61703-161-02)

Ingredients (1)

methotrexate sodium (25 mg/mL)

Linked Drug Pages (1)

Methotrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["1655956", "1946772"], "spl_set_id": ["bd287e89-32f9-4396-95fa-4b562869f476"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 CARTON (61703-161-05)  / 2 mL in 1 VIAL, MULTI-DOSE (61703-161-02)", "package_ndc": "61703-161-05", "marketing_start_date": "20241104"}], "brand_name": "Methotrexate", "product_id": "61703-161_6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "61703-161", "generic_name": "Methotrexate", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "25 mg/mL"}], "application_number": "NDA011719", "marketing_category": "NDA", "marketing_start_date": "20241104", "listing_expiration_date": "20261231"}