Melphalan Hydrochloride

Orange BookSPL

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

Identification

ManufacturerAvenacy Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8363420261
1 KIT in 1 CARTON (83634-202-61) * 15 mL in 1 VIAL, SINGLE-DOSE (83634-200-15) * 10 mL in 1 VIAL, SINGLE-USE (83634-201-10)

Annotations

Orange Book

A211463

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": "83634-202_47da36c6-67e2-44c7-93d8-4f236abb73e7",
  "productndc": "83634-202",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211463",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 13, 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": "ANDA211463",
  "marketing_category": "ANDA",
  "nonproprietary_name": "melphalan hydrochloride",
  "start_marketing_date": "20231218",
  "active_numerator_strength": null
}

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