MELPHALAN HYDROCHLORIDE

Orange BookSPL

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3172236231
1 KIT in 1 CARTON (31722-362-31) * 10 mL in 1 VIAL, SINGLE-DOSE (31722-360-31) * 10 mL in 1 VIAL, SINGLE-USE (31722-361-31)

Annotations

Orange Book

A215024

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": "31722-362_1b6485c8-5ec7-6fbe-e063-6394a90ac531",
  "productndc": "31722-362",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215024",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 23, 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": "ANDA215024",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MELPHALAN HYDROCHLORIDE",
  "start_marketing_date": "20240523",
  "active_numerator_strength": null
}

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