xatmep

Generic: methotrexate

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xatmep
Generic Name methotrexate
Labeler azurity pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methotrexate 2.5 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52652-2001
Product ID 52652-2001_461e9d94-1451-904d-e063-6294a90a05f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208400
Listing Expiration 2026-12-31
Marketing Start 2017-05-01

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 526522001
Hyphenated Format 52652-2001

Supplemental Identifiers

RxCUI
1921592 1921598
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 xatmep (source: ndc)
Generic Name methotrexate (source: ndc)
Application Number NDA208400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (52652-2001-1)
  • 60 mL in 1 BOTTLE (52652-2001-6)
source: ndc

Packages (2)

52652-2001-1 120 mL in 1 BOTTLE (52652-2001-1) 52652-2001-6 60 mL in 1 BOTTLE (52652-2001-6)

Ingredients (1)

methotrexate (2.5 mg/mL)

Linked Drug Pages (1)

Xatmep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "461e9d94-1451-904d-e063-6294a90a05f4", "openfda": {"nui": ["N0000175584", "N0000000111"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["1921592", "1921598"], "spl_set_id": ["aec9984e-34c5-481b-b6bf-9bb5caf1daf8"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (52652-2001-1)", "package_ndc": "52652-2001-1", "marketing_start_date": "20170501"}, {"sample": false, "description": "60 mL in 1 BOTTLE (52652-2001-6)", "package_ndc": "52652-2001-6", "marketing_start_date": "20180813"}], "brand_name": "Xatmep", "product_id": "52652-2001_461e9d94-1451-904d-e063-6294a90a05f4", "dosage_form": "SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "52652-2001", "generic_name": "Methotrexate", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xatmep", "active_ingredients": [{"name": "METHOTREXATE", "strength": "2.5 mg/mL"}], "application_number": "NDA208400", "marketing_category": "NDA", "marketing_start_date": "20170501", "listing_expiration_date": "20261231"}