methotrexate

Generic: methotrexate

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3765
Product ID 68071-3765_2bae0372-8ccb-0028-e063-6294a90a889f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210454
Listing Expiration 2026-12-31
Marketing Start 2020-01-30

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 680713765
Hyphenated Format 68071-3765

Supplemental Identifiers

RxCUI
105585
UPC
0368071376593
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 ANDA210454 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (68071-3765-6)
  • 90 TABLET in 1 BOTTLE (68071-3765-9)
source: ndc

Packages (2)

Ingredients (1)

methotrexate sodium (2.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2bae0372-8ccb-0028-e063-6294a90a889f", "openfda": {"upc": ["0368071376593"], "unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["2b61822e-b488-5eaf-e063-6394a90a2dcd"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3765-6)", "package_ndc": "68071-3765-6", "marketing_start_date": "20250114"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3765-9)", "package_ndc": "68071-3765-9", "marketing_start_date": "20250110"}], "brand_name": "Methotrexate", "product_id": "68071-3765_2bae0372-8ccb-0028-e063-6294a90a889f", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "68071-3765", "generic_name": "Methotrexate", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA210454", "marketing_category": "ANDA", "marketing_start_date": "20200130", "listing_expiration_date": "20261231"}