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United States · US · US:83709-001_9db61e18-114c-46c5-bdc2-5f56c4b2f87f
XTORO
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFonseca Biosciences, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1183709001011 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER
- ndc1183709001901 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER
- ndc1183709001911 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
D26OSN9Q4R
FINAFLOXACIN
RxCUI 1598641
Orange Book
N206307
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D26OSN9Q4R",
"rxcui": "1598641",
"inchikey": "FYMHQCNFKNMJAV-HOTGVXAUSA-N",
"display_name": "FINAFLOXACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"5c628272-019e-4511-8d5c-dcf56023da25": {
"match": "brand_token",
"title": "XTORO (FINAFLOXACIN) SUSPENSION [FONSECA BIOSCIENCES, LLC]",
"spl_version": "1",
"published_date": "2026-05-01"
}
},
"productid": "83709-001_9db61e18-114c-46c5-bdc2-5f56c4b2f87f",
"productndc": "83709-001",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "206307",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3%",
"product_no": "001",
"approval_date": "Dec 17, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FINAFLOXACIN",
"proprietary_name": "XTORO",
"active_ingred_unit": "mg/mL",
"application_number": "NDA206307",
"marketing_category": "NDA",
"nonproprietary_name": "finafloxacin",
"start_marketing_date": "20260501",
"active_numerator_strength": "3"
}Access this data programmatically
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