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United States · US · US:45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051
Fludarabine phosphate
Orange BookUNIISPLATC L01BB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeL01BB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145963609551 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
1X9VK9O1SC
FLUDARABINE PHOSPHATE
RxCUI 25102
Orange Book
A078610
AP
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": "45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051",
"productndc": "45963-609",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "078610",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "Feb 11, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUDARABINE PHOSPHATE",
"proprietary_name": "Fludarabine phosphate",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA078610",
"marketing_category": "ANDA",
"nonproprietary_name": "Fludarabine phosphate",
"start_marketing_date": "20150105",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01BB05.
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