methotrexate

Generic: methotrexate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-182
Product ID 59651-182_ce7eea99-c2b2-41c8-b577-3e7f3a29b739
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 59651182
Hyphenated Format 59651-182

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-182-01)
  • 36 TABLET in 1 BOTTLE (59651-182-36)
source: ndc

Packages (2)

59651-182-01 100 TABLET in 1 BOTTLE (59651-182-01) 59651-182-36 36 TABLET in 1 BOTTLE (59651-182-36)

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": "ce7eea99-c2b2-41c8-b577-3e7f3a29b739", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["09931d44-a3f8-49dc-a3f2-b527ee4214bf"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-182-01)", "package_ndc": "59651-182-01", "marketing_start_date": "20200130"}, {"sample": false, "description": "36 TABLET in 1 BOTTLE (59651-182-36)", "package_ndc": "59651-182-36", "marketing_start_date": "20200130"}], "brand_name": "Methotrexate", "product_id": "59651-182_ce7eea99-c2b2-41c8-b577-3e7f3a29b739", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "59651-182", "generic_name": "Methotrexate", "labeler_name": "Aurobindo Pharma Limited", "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"}