methotrexate

Generic: methotrexate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1524
Product ID 67046-1524_2f20d43e-a477-a839-e063-6394a90ace38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213343
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

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 670461524
Hyphenated Format 67046-1524

Supplemental Identifiers

RxCUI
105585
UNII
3IG1E710ZN

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 ANDA213343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1524-3)
source: ndc

Packages (1)

67046-1524-3 30 TABLET in 1 BLISTER PACK (67046-1524-3)

Ingredients (1)

methotrexate sodium (2.5 mg/1)

Linked Drug Pages (1)

Methotrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f20d43e-a477-a839-e063-6394a90ace38", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["2f20d43e-a4b3-a839-e063-6394a90ace38"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1524-3)", "package_ndc": "67046-1524-3", "marketing_start_date": "20250227"}], "brand_name": "Methotrexate", "product_id": "67046-1524_2f20d43e-a477-a839-e063-6394a90ace38", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "67046-1524", "generic_name": "Methotrexate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA213343", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}