methotrexate

Generic: methotrexate

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

Drug Facts

Product Profile

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

methotrexate sodium 2.5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0014
Product ID 0378-0014_8088c399-5814-4d51-84fc-e95edd5751f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081235
Listing Expiration 2026-12-31
Marketing Start 1992-05-18

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 03780014
Hyphenated Format 0378-0014

Supplemental Identifiers

RxCUI
105585
UPC
0303780014015
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 ANDA081235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)
source: ndc

Packages (1)

0378-0014-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)

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": "8088c399-5814-4d51-84fc-e95edd5751f5", "openfda": {"upc": ["0303780014015"], "unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["70c09984-2b36-424f-8b27-3fd0cd4e833d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)", "package_ndc": "0378-0014-01", "marketing_start_date": "19920518"}], "brand_name": "Methotrexate", "product_id": "0378-0014_8088c399-5814-4d51-84fc-e95edd5751f5", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0378-0014", "generic_name": "methotrexate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA081235", "marketing_category": "ANDA", "marketing_start_date": "19920518", "listing_expiration_date": "20261231"}