grafapex

Generic: treosulfan

Labeler: medexus pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name grafapex
Generic Name treosulfan
Labeler medexus pharma, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

treosulfan 1000 mg/g

Manufacturer
Medexus Pharma, Inc.

Identifiers & Regulatory

Product NDC 59137-335
Product ID 59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214759
Listing Expiration 2026-12-31
Marketing Start 2025-01-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59137335
Hyphenated Format 59137-335

Supplemental Identifiers

RxCUI
2703570 2703575 2703577 2703579
UNII
CO61ER3EPI

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 grafapex (source: ndc)
Generic Name treosulfan (source: ndc)
Application Number NDA214759 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 mg/g
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL
source: ndc

Packages (1)

59137-335-01 1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL

Ingredients (1)

treosulfan (1000 mg/g)

Linked Drug Pages (1)

GRAFAPEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2d06b03c-17aa-0492-e063-6294a90abd8f", "openfda": {"unii": ["CO61ER3EPI"], "rxcui": ["2703570", "2703575", "2703577", "2703579"], "spl_set_id": ["2d06b03c-17aa-0492-e063-6294a90abd8f"], "manufacturer_name": ["Medexus Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (59137-335-01)  / 1 g in 1 VIAL", "package_ndc": "59137-335-01", "marketing_start_date": "20250128"}], "brand_name": "GRAFAPEX", "product_id": "59137-335_2d06b03c-17aa-0492-e063-6294a90abd8f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "59137-335", "generic_name": "treosulfan", "labeler_name": "Medexus Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GRAFAPEX", "active_ingredients": [{"name": "TREOSULFAN", "strength": "1000 mg/g"}], "application_number": "NDA214759", "marketing_category": "NDA", "marketing_start_date": "20250128", "listing_expiration_date": "20261231"}