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United States · US · US:63323-192_fc26c9ee-50de-4eff-b264-1882edd65414
Fludarabine
Orange BookUNIISPLATC L01BB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323192021 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
1X9VK9O1SC
FLUDARABINE PHOSPHATE
RxCUI 25102
Orange Book
A078393
AP1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1X9VK9O1SC",
"rxcui": "25102",
"inchikey": "GIUYCYHIANZCFB-FJFJXFQQSA-N",
"display_name": "FLUDARABINE PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"cf5255cc-91fd-4132-973b-764dba142eae": {
"match": "brand_token",
"title": "FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "5",
"published_date": "2024-10-21"
}
},
"productid": "63323-192_fc26c9ee-50de-4eff-b264-1882edd65414",
"productndc": "63323-192",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078393",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP1",
"strength": "50MG/2ML (25MG/ML)",
"product_no": "001",
"approval_date": "Oct 15, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUDARABINE PHOSPHATE",
"proprietary_name": "Fludarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078393",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUDARABINE PHOSPHATE",
"start_marketing_date": "20071116",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01BB05.
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