Melphalan hydrochloride

Orange BookSPL

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

Identification

ManufacturerBPI Labs LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5428810902
1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01)

Annotations

Orange Book

A209197

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": "54288-109_731e5310-a610-419d-bae0-89d4d2702731",
  "productndc": "54288-109",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Melphalan hydrochloride",
  "active_ingred_unit": null,
  "application_number": "ANDA209197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Melphalan Hydrochloride",
  "start_marketing_date": "20210702",
  "active_numerator_strength": null
}

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