methotrexate

Generic: methotrexate sodium

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate sodium
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-235
Product ID 47335-235_15524c15-09e2-4eb2-bba7-a5e51d8ead07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201749
Listing Expiration 2026-12-31
Marketing Start 2017-11-10

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 47335235
Hyphenated Format 47335-235

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 sodium (source: ndc)
Application Number ANDA201749 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (47335-235-83)
  • 36 TABLET in 1 BOTTLE (47335-235-96)
source: ndc

Packages (2)

47335-235-83 100 TABLET in 1 BOTTLE (47335-235-83) 47335-235-96 36 TABLET in 1 BOTTLE (47335-235-96)

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": "15524c15-09e2-4eb2-bba7-a5e51d8ead07", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["8f1260de-b60c-4f0e-8af6-0e957b0a281b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (47335-235-83)", "package_ndc": "47335-235-83", "marketing_start_date": "20171110"}, {"sample": false, "description": "36 TABLET in 1 BOTTLE (47335-235-96)", "package_ndc": "47335-235-96", "marketing_start_date": "20171110"}], "brand_name": "Methotrexate", "product_id": "47335-235_15524c15-09e2-4eb2-bba7-a5e51d8ead07", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "47335-235", "generic_name": "Methotrexate Sodium", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA201749", "marketing_category": "ANDA", "marketing_start_date": "20171110", "listing_expiration_date": "20261231"}