methotrexate

Generic: methotrexate

Labeler: teva parenteral medicines, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler teva parenteral medicines, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
Active Ingredients

methotrexate sodium 25 mg/mL

Manufacturer
Teva Parenteral Medicines, Inc.

Identifiers & Regulatory

Product NDC 0703-3678
Product ID 0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040843
Listing Expiration 2026-12-31
Marketing Start 2012-08-01

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 07033678
Hyphenated Format 0703-3678

Supplemental Identifiers

RxCUI
1655956 1655959 1655960
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 ANDA040843 (source: ndc)
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0703-3678-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE

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": ["INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS"], "spl_id": "e81074cc-12b4-4ac9-a5bb-749188989b2c", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["1655956", "1655959", "1655960"], "spl_set_id": ["346ec9ce-dc98-4a55-b55e-d3af11f2d703"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01)  / 40 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0703-3678-01", "marketing_start_date": "20120801"}], "brand_name": "Methotrexate", "product_id": "0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0703-3678", "generic_name": "Methotrexate", "labeler_name": "Teva Parenteral Medicines, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "25 mg/mL"}], "application_number": "ANDA040843", "marketing_category": "ANDA", "marketing_start_date": "20120801", "listing_expiration_date": "20261231"}