evomela

Generic: melphalan

Labeler: acrotech biopharma inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name evomela
Generic Name melphalan
Labeler acrotech biopharma inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

melphalan hydrochloride 50 mg/10mL

Manufacturer
Acrotech Biopharma Inc

Identifiers & Regulatory

Product NDC 72893-001
Product ID 72893-001_4dd3db2d-aa56-4952-bcad-70fa22e8e93c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207155
Listing Expiration 2026-12-31
Marketing Start 2016-03-31

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72893001
Hyphenated Format 72893-001

Supplemental Identifiers

RxCUI
311487 1745090
UNII
1VXP4V453T

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 evomela (source: ndc)
Generic Name melphalan (source: ndc)
Application Number NDA207155 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

72893-001-01 1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL

Ingredients (1)

melphalan hydrochloride (50 mg/10mL)

Linked Drug Pages (1)

EVOMELA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4dd3db2d-aa56-4952-bcad-70fa22e8e93c", "openfda": {"unii": ["1VXP4V453T"], "rxcui": ["311487", "1745090"], "spl_set_id": ["69f55869-dc11-408e-8fc7-47634269a52c"], "manufacturer_name": ["Acrotech Biopharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (72893-001-01)  / 20 mL in 1 VIAL", "package_ndc": "72893-001-01", "marketing_start_date": "20160331"}], "brand_name": "EVOMELA", "product_id": "72893-001_4dd3db2d-aa56-4952-bcad-70fa22e8e93c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "72893-001", "generic_name": "Melphalan", "labeler_name": "Acrotech Biopharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EVOMELA", "active_ingredients": [{"name": "MELPHALAN HYDROCHLORIDE", "strength": "50 mg/10mL"}], "application_number": "NDA207155", "marketing_category": "NDA", "marketing_start_date": "20160331", "listing_expiration_date": "20261231"}