methotrexate

Generic: methotrexate

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

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
Active Ingredients

methotrexate 25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9516
Product ID 0143-9516_3046ff78-3565-46d1-a88b-283e5ff6e7c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089343
Listing Expiration 2026-12-31
Marketing Start 2018-01-05

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]
Mechanism of Action
folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439516
Hyphenated Format 0143-9516

Supplemental Identifiers

RxCUI
1655959 1655960 1655967 1655968
UNII
YL5FZ2Y5U1
NUI
N0000175584 N0000000111

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 ANDA089343 (source: ndc)
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9516-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0143-9516-01 1 VIAL in 1 BOX (0143-9516-01) / 10 mL in 1 VIAL

Ingredients (1)

methotrexate (25 mg/mL)

Linked Drug Pages (1)

Methotrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS"], "spl_id": "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "openfda": {"nui": ["N0000175584", "N0000000111"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["1655959", "1655960", "1655967", "1655968"], "spl_set_id": ["3989d30d-56e5-4e8d-9379-c30fecc894f2"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9516-01)  / 10 mL in 1 VIAL", "package_ndc": "0143-9516-01", "marketing_start_date": "20180105"}], "brand_name": "Methotrexate", "product_id": "0143-9516_3046ff78-3565-46d1-a88b-283e5ff6e7c3", "dosage_form": "SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0143-9516", "generic_name": "Methotrexate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE", "strength": "25 mg/mL"}], "application_number": "ANDA089343", "marketing_category": "ANDA", "marketing_start_date": "20180105", "listing_expiration_date": "20261231"}