Home NDC 83709-001 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206307-001 XTORO FINAFLOXACIN 0.3% SUSPENSION/DROPS / OTIC RLD, RS 2014-12-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206307-001 9119859 2030-07-02 U-1679 2015-09-15 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD, RS 2014-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD, RS 2014-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206307-001 XTORO 0.3% SUSPENSION/DROPS / OTIC RLD 2014-12-17 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 161 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206307-001 9119859 2030-07-02 U-1679 2015-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206307-001 9993483 2030-07-02 Drug product 2022-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206307-001 8536167 2031-08-08 U-1679 2015-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206307-001 9504691 2033-11-21 U-1679 Drug product 2016-12-16 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base XTORO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINAFLOXACIN 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D26OSN9Q4R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1598645 Internal RxNorm lookup 1598650 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83709-001-01 83709000101 1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER 2026-05-01 No No Current 83709-001-90 83709000190 1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER 1 pouch 2026-05-01 Yes No Current 83709-001-91 83709000191 1 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER 2026-05-01 Yes No Current