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United States · US · US:16729-351_0e2ef789-efb4-8395-e063-6294a90a9145

Busulfan

In shortageOrange BookUNIISPLATC L01AB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAccord Healthcare, Inc
CountryUS (United States)
ATC codeL01AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1672935192
    8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)

Annotations

UNII (FDA Substance ID)
G1LN9045DK
BUSULFAN
RxCUI 1828
Orange Book
A210148
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Busulfan Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "G1LN9045DK",
    "rxcui": "1828",
    "inchikey": "COVZYZSDYWQREU-UHFFFAOYSA-N",
    "display_name": "BUSULFAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "06883ac0-4b2a-4f26-89bf-512d37b9ba7f": {
      "match": "brand_token",
      "title": "BUSULFAN INJECTION, SOLUTION [EUGIA US LLC]",
      "spl_version": "1",
      "published_date": "2024-06-28"
    }
  },
  "productid": "16729-351_0e2ef789-efb4-8395-e063-6294a90a9145",
  "productndc": "16729-351",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "210148",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6MG/ML",
        "product_no": "001",
        "approval_date": "Feb 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUSULFAN",
  "shortage_reason": "Busulfan Injection",
  "shortage_status": "current",
  "proprietary_name": "Busulfan",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210148",
  "marketing_category": "ANDA",
  "nonproprietary_name": "busulfan",
  "start_marketing_date": "20190722",
  "active_numerator_strength": "6"
}

Related drugs

Other records sharing ATC code L01AB01.

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