methotrexate

Generic: methotrexate

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-486
Product ID 16729-486_424d715c-25c3-6376-e063-6294a90a2ef4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213343
Listing Expiration 2026-12-31
Marketing Start 2020-08-24

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 16729486
Hyphenated Format 16729-486

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 ANDA213343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-486-01)
source: ndc

Packages (1)

16729-486-01 100 TABLET in 1 BOTTLE (16729-486-01)

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": "424d715c-25c3-6376-e063-6294a90a2ef4", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["874c7f43-a3be-4236-89cc-24c44e3c5813"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-486-01)", "package_ndc": "16729-486-01", "marketing_start_date": "20200824"}], "brand_name": "Methotrexate", "product_id": "16729-486_424d715c-25c3-6376-e063-6294a90a2ef4", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "16729-486", "generic_name": "Methotrexate", "labeler_name": "Accord Healthcare Inc.", "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": "20200824", "listing_expiration_date": "20261231"}