methotrexate

Generic: methotrexate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

methotrexate 2.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-554
Product ID 50268-554_4992f7cb-30dc-6354-e063-6294a90a6784
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207812
Listing Expiration 2027-12-31
Marketing Start 2026-01-29

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]
Mechanism of Action
folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268554
Hyphenated Format 50268-554

Supplemental Identifiers

RxCUI
105585
UNII
YL5FZ2Y5U1
NUI
N0000175584 N0000000111

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 ANDA207812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-554-15) / 1 TABLET in 1 BLISTER PACK (50268-554-11)
source: ndc

Packages (1)

50268-554-15 50 BLISTER PACK in 1 BOX (50268-554-15) / 1 TABLET in 1 BLISTER PACK (50268-554-11)

Ingredients (1)

methotrexate (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": "4992f7cb-30dc-6354-e063-6294a90a6784", "openfda": {"nui": ["N0000175584", "N0000000111"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["105585"], "spl_set_id": ["4992fdaa-b880-ee25-e063-6394a90af03b"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-554-15)  / 1 TABLET in 1 BLISTER PACK (50268-554-11)", "package_ndc": "50268-554-15", "marketing_start_date": "20260129"}], "brand_name": "Methotrexate", "product_id": "50268-554_4992f7cb-30dc-6354-e063-6294a90a6784", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "50268-554", "generic_name": "Methotrexate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE", "strength": "2.5 mg/1"}], "application_number": "ANDA207812", "marketing_category": "ANDA", "marketing_start_date": "20260129", "listing_expiration_date": "20271231"}