methotrexate

Generic: methotrexate

Labeler: safecor health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler safecor health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Safecor Health LLC

Identifiers & Regulatory

Product NDC 48433-065
Product ID 48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA081235
Listing Expiration 2027-12-31
Marketing Start 2026-01-19

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 48433065
Hyphenated Format 48433-065

Supplemental Identifiers

RxCUI
105585
UNII
3IG1E710ZN

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
  • 20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01)
source: ndc

Packages (1)

48433-065-05 20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01)

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": "49a1fdee-5587-e05a-e063-6294a90aebc5", "openfda": {"unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["f177e6fa-c482-432d-8208-937468ab3f10"], "manufacturer_name": ["Safecor Health LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (48433-065-05)  / 1 TABLET in 1 BLISTER PACK (48433-065-01)", "package_ndc": "48433-065-05", "marketing_start_date": "20260119"}], "brand_name": "Methotrexate", "product_id": "48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "48433-065", "generic_name": "methotrexate", "labeler_name": "Safecor Health LLC", "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": "20260119", "listing_expiration_date": "20271231"}