Dacarbazine

Orange BookUNIISPLATC L01AX04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL01AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143924510
10 VIAL in 1 CARTON (0143-9245-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9245-01)

Annotations

UNII (FDA Substance ID)

7GR28W0FJI

DACARBAZINE

RxCUI 3098

Orange Book

A075812

APAP

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": "0143-9245_bbbf119e-26f4-46c1-ba80-de927e51c566",
  "productndc": "0143-9245",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "075812",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 15, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 31, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DACARBAZINE",
  "proprietary_name": "Dacarbazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dacarbazine",
  "start_marketing_date": "20010808",
  "active_numerator_strength": "200"
}

Related drugs

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