FDA.reportPublic FDA data

XTORO

Product NDC
83709-001
11-digit product format
837090001
Labeler code
83709
Product ID
83709-001_9db61e18-114c-46c5-bdc2-5f56c4b2f87f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
finafloxacin
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
Fonseca Biosciences, LLC
Application
NDA206307
Marketing category
NDA
Marketing start
2026-05-01
Substance
FINAFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XTORO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINAFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD26OSN9Q4R
Rxcui1598645, 1598650

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83709-001-01XTORO5 mL in 1 BOTTLE, DROPPERSUSPENSION51
83709-001-01XTORO1 in 1 CARTONSUSPENSION11
83709-001-90XTORO1 in 1 POUCHSUSPENSION11
83709-001-90XTORO1 in 1 CARTONSUSPENSION11
83709-001-91XTORO1 in 1 CARTONSUSPENSION11
83709-001-91XTORO5 mL in 1 BOTTLE, DROPPERSUSPENSION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598645finafloxacin 0.3 % Otic SuspensionPSN5c628272-019e-4511-8d5c-dcf56023da251
1598650Xtoro 0.3 % Otic SuspensionPSN5c628272-019e-4511-8d5c-dcf56023da251
1598650finafloxacin 3 MG/ML Otic Suspension [Xtoro]SBD5c628272-019e-4511-8d5c-dcf56023da251
1598645finafloxacin 3 MG/ML Otic SuspensionSCD5c628272-019e-4511-8d5c-dcf56023da251
1598645finafloxacin 0.3 % Otic SuspensionSY5c628272-019e-4511-8d5c-dcf56023da251
1598650Xtoro 0.3 % Otic SuspensionSY5c628272-019e-4511-8d5c-dcf56023da251
1598650Xtoro 3 MG/ML Otic SuspensionSY5c628272-019e-4511-8d5c-dcf56023da251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83709-001-01837090001011 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER2026-05-01NoNoCurrent
83709-001-90837090001901 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER1 pouch2026-05-01YesNoCurrent
83709-001-91837090001911 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER2026-05-01YesNoCurrent