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United States · US · US:70121-1244_973e7d91-192a-4dea-9056-4f98c37cdc6f

Busulfan

In shortageOrange BookUNIISPLATC L01AB01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012112447
    8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)

Annotations

UNII (FDA Substance ID)
G1LN9045DK
BUSULFAN
RxCUI 1828
Orange Book
A209580
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": "70121-1244_973e7d91-192a-4dea-9056-4f98c37cdc6f",
  "productndc": "70121-1244",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209580",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6MG/ML",
        "product_no": "001",
        "approval_date": "Dec 18, 2017"
      }
    ],
    "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": "ANDA209580",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Busulfan",
  "start_marketing_date": "20171218",
  "active_numerator_strength": "6"
}

Related drugs

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