methotrexate sodium

Generic: methotrexate sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate sodium
Generic Name methotrexate sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-4550
Product ID 0054-4550_4a9b1d2c-4371-4140-ab3d-4a440af87362
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040054
Listing Expiration 2026-12-31
Marketing Start 1994-08-01

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 00544550
Hyphenated Format 0054-4550

Supplemental Identifiers

RxCUI
105585
UPC
0300544550154
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 sodium (source: ndc)
Generic Name methotrexate sodium (source: ndc)
Application Number ANDA040054 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25)
source: ndc

Packages (1)

0054-4550-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25)

Ingredients (1)

methotrexate sodium (2.5 mg/1)

Linked Drug Pages (1)

Methotrexate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a9b1d2c-4371-4140-ab3d-4a440af87362", "openfda": {"upc": ["0300544550154"], "unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["d71b1856-99d8-4a9e-9189-f87b6675f80a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25)", "package_ndc": "0054-4550-25", "marketing_start_date": "19940801"}], "brand_name": "Methotrexate Sodium", "product_id": "0054-4550_4a9b1d2c-4371-4140-ab3d-4a440af87362", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0054-4550", "generic_name": "Methotrexate Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate Sodium", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA040054", "marketing_category": "ANDA", "marketing_start_date": "19940801", "listing_expiration_date": "20261231"}