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United States · US · US:63323-136_93aba071-101f-4610-90fa-27e3635b2c1c

Bleomycin

In shortageOrange BookUNIISPLATC L01DC01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332313610
    1 VIAL in 1 CARTON (63323-136-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
7DP3NTV15T
BLEOMYCIN SULFATE
RxCUI 1621
Orange Book
A065185
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bleomycin Sulfate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "7DP3NTV15T",
    "rxcui": "1621",
    "inchikey": null,
    "display_name": "BLEOMYCIN SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "640602f9-a7df-46f0-a9b1-19c471008bee": {
      "match": "brand_token",
      "title": "BLEOMYCIN (BLEOMYCIN SULFATE) POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-04-22"
    }
  },
  "productid": "63323-136_93aba071-101f-4610-90fa-27e3635b2c1c",
  "productndc": "63323-136",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065185",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 15 UNITS BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 28, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 30 UNITS BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 28, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BLEOMYCIN SULFATE",
  "shortage_reason": "Bleomycin Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Bleomycin",
  "active_ingred_unit": "[USP'U]/1",
  "application_number": "ANDA065185",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BLEOMYCIN SULFATE",
  "start_marketing_date": "20090213",
  "active_numerator_strength": "15"
}

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