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United States · US · US:61703-332_6615dbd2-3bb4-40b5-8599-aa46bc0bc488

Bleomycin

In shortageOrange BookUNIISPLATC L01DC01

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeL01DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6170333218
    1 VIAL, SINGLE-DOSE in 1 CARTON (61703-332-18) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7DP3NTV15T
BLEOMYCIN SULFATE
RxCUI 1621
Orange Book
A065031
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": "61703-332_6615dbd2-3bb4-40b5-8599-aa46bc0bc488",
  "productndc": "61703-332",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065031",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 15 UNITS BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 10, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 30 UNITS BASE/VIAL",
        "product_no": "002",
        "approval_date": "Mar 10, 2000"
      }
    ],
    "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": "ANDA065031",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BLEOMYCIN",
  "start_marketing_date": "20000411",
  "active_numerator_strength": "15"
}

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