Melphalan Hydrochloride

Orange BookSPL

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2502125861
1 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10)

Annotations

Orange Book

A209826

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "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": "25021-258_6c52e5c7-4b97-451c-aacd-b43046fd164a",
  "productndc": "25021-258",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209826",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 28, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Melphalan Hydrochloride",
  "active_ingred_unit": null,
  "application_number": "ANDA209826",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Melphalan Hydrochloride",
  "start_marketing_date": "20240401",
  "active_numerator_strength": null
}

Access this data programmatically

Query Melphalan Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs