Dacarbazine

Orange BookUNIISPLATC L01AX04

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeL01AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332312820
10 VIAL, SINGLE-DOSE in 1 TRAY (63323-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-128-00)

Annotations

UNII (FDA Substance ID)

7GR28W0FJI

DACARBAZINE

RxCUI 3098

Orange Book

A075371

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7GR28W0FJI",
    "rxcui": "3098",
    "inchikey": "FDKXTQMXEQVLRF-ZHACJKMWSA-N",
    "display_name": "DACARBAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0d81315c-7021-4091-b703-ad135390c936": {
      "match": "brand_token",
      "title": "DACARBAZINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "6",
      "published_date": "2025-09-29"
    }
  },
  "productid": "63323-128_04644165-06c9-4a55-a026-a529d824cc90",
  "productndc": "63323-128",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "075371",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 27, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/VIAL",
        "product_no": "002",
        "approval_date": "Aug 27, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DACARBAZINE",
  "proprietary_name": "Dacarbazine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075371",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DACARBAZINE",
  "start_marketing_date": "20010907",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code L01AX04.

Access this data programmatically

Query Dacarbazine 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