🇺🇸
United States · US · US:0409-0801_e2a13722-66e8-48df-bf6a-65eca64068e6
Nipent
Orange BookUNIISPLATC L01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeL01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104090801011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
395575MZO7
PENTOSTATIN
RxCUI 8011
Orange Book
N020122
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "395575MZO7",
"rxcui": "8011",
"inchikey": "FPVKHBSQESCIEP-JQCXWYLXSA-N",
"display_name": "PENTOSTATIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"674e0e6d-46ed-4868-9196-04019d667716": {
"match": "brand_token",
"title": "NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]",
"spl_version": "26",
"published_date": "2025-11-18"
}
},
"productid": "0409-0801_e2a13722-66e8-48df-bf6a-65eca64068e6",
"productndc": "0409-0801",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "020122",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "10MG/VIAL",
"product_no": "001",
"approval_date": "Oct 11, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PENTOSTATIN",
"proprietary_name": "Nipent",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020122",
"marketing_category": "NDA",
"nonproprietary_name": "PENTOSTATIN",
"start_marketing_date": "20070815",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01XX08.
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- IENIPENT 10 mg powder for solution for injection, powder for solution for infusionPfizer Healthcare Ireland Unlimited Company
- 🇫🇷NIPENT 10 mg, poudre pour solution pour injection, poudre pour solution pour perfusionPFIZER HOLDING FRANCE
- GBNipent 10mg powder for solution for injection vialsPfizer Ltd
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