methotrexate sodium

Generic: methotrexate sodium

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate sodium
Generic Name methotrexate sodium
Labeler elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-330
Product ID 64850-330_8dde104c-5e16-4d3b-93ae-2a464e033270
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216453
Listing Expiration 2026-12-31
Marketing Start 2024-05-16

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 64850330
Hyphenated Format 64850-330

Supplemental Identifiers

RxCUI
105585
UPC
0364850330015
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 ANDA216453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01)
source: ndc

Packages (1)

64850-330-01 100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01)

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": "8dde104c-5e16-4d3b-93ae-2a464e033270", "openfda": {"upc": ["0364850330015"], "unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["89c05ea3-3be1-46dd-b112-29c436fd7289"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01)", "package_ndc": "64850-330-01", "marketing_start_date": "20240516"}], "brand_name": "Methotrexate Sodium", "product_id": "64850-330_8dde104c-5e16-4d3b-93ae-2a464e033270", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "64850-330", "generic_name": "Methotrexate Sodium", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate Sodium", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA216453", "marketing_category": "ANDA", "marketing_start_date": "20240516", "listing_expiration_date": "20261231"}