Melphalan hydrochloride

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315535541
1 KIT in 1 CARTON (23155-355-41) * 10 mL in 1 VIAL (23155-353-31) * 10 mL in 1 VIAL (23155-354-31)

Annotations

Orange Book

A206523

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "e9c2efee-173d-4795-96d8-7aae5b3a3073": {
      "match": "brand_token",
      "title": "MELPHALAN (MELPHALAN HYDROCHLORIDE) KIT [FRESENIUS KABI USA, LLC]",
      "spl_version": "6",
      "published_date": "2026-02-13"
    }
  },
  "productid": "23155-355_64df9058-d4f2-4301-b5e4-19e3aed9747c",
  "productndc": "23155-355",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 29, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Melphalan hydrochloride",
  "active_ingred_unit": null,
  "application_number": "ANDA206523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Melphalan hydrochloride",
  "start_marketing_date": "20250328",
  "active_numerator_strength": null
}

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