methotrexate

Generic: methotrexate

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

methotrexate sodium 200 mg/8mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-512
Product ID 55150-512_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201529
Listing Expiration 2026-12-31
Marketing Start 2024-09-11

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 55150512
Hyphenated Format 55150-512

Supplemental Identifiers

RxCUI
1655959 1655960 1655967 1655968
UPC
0355150510016 0355150510054 0355150511013
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 ANDA201529 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/8mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-01) / 8 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-10) / 8 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-512-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-01) / 8 mL in 1 VIAL, SINGLE-DOSE 55150-512-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-10) / 8 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

methotrexate sodium (200 mg/8mL)

Linked Drug Pages (1)

METHOTREXATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "openfda": {"upc": ["0355150510016", "0355150510054", "0355150511013"], "unii": ["3IG1E710ZN"], "rxcui": ["1655959", "1655960", "1655967", "1655968"], "spl_set_id": ["63bb6fbf-dd59-4edc-af8f-d0c397ca1262"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-01)  / 8 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-512-01", "marketing_start_date": "20240911"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-512-10)  / 8 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-512-10", "marketing_start_date": "20240911"}], "brand_name": "METHOTREXATE", "product_id": "55150-512_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "55150-512", "generic_name": "METHOTREXATE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHOTREXATE", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "200 mg/8mL"}], "application_number": "ANDA201529", "marketing_category": "ANDA", "marketing_start_date": "20240911", "listing_expiration_date": "20261231"}