ivra

Generic: melphalan hcl

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivra
Generic Name melphalan hcl
Labeler apotex corp
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

melphalan hydrochloride 90 mg/mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6414
Product ID 60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217110
Listing Expiration 2026-12-31
Marketing Start 2025-05-09

Pharmacologic Class

Classes
alkylating activity [moa] alkylating drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056414
Hyphenated Format 60505-6414

Supplemental Identifiers

RxCUI
2708998 2709003
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 ivra (source: ndc)
Generic Name melphalan hcl (source: ndc)
Application Number NDA217110 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 90 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

60505-6414-1 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

melphalan hydrochloride (90 mg/mL)

Linked Drug Pages (1)

IVRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1aaa2d67-c709-f01c-026d-0eaa8f47c5d1", "openfda": {"unii": ["1VXP4V453T"], "rxcui": ["2708998", "2709003"], "spl_set_id": ["c23e868a-dc62-2181-5099-76c9226602b2"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1)  / 3 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "60505-6414-1", "marketing_start_date": "20250509"}], "brand_name": "IVRA", "product_id": "60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "60505-6414", "generic_name": "melphalan HCl", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IVRA", "active_ingredients": [{"name": "MELPHALAN HYDROCHLORIDE", "strength": "90 mg/mL"}], "application_number": "NDA217110", "marketing_category": "NDA", "marketing_start_date": "20250509", "listing_expiration_date": "20261231"}