Melphalan

Orange BookSPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332376020
1 KIT in 1 CARTON (63323-760-20) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20) * 10 mL in 1 VIAL, SINGLE-USE (63323-732-10)

Annotations

Orange Book

A203393

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": "63323-760_f3373f9b-1680-411c-922f-df58a559a6aa",
  "productndc": "63323-760",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203393",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Melphalan",
  "active_ingred_unit": null,
  "application_number": "ANDA203393",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Melphalan Hydrochloride",
  "start_marketing_date": "20171222",
  "active_numerator_strength": null
}

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