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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
- ndc1163323136101 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"
}Related drugs
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