Besivance

Product NDC: 85766-260
Requested package NDC: 85766-260-05
11-digit product format: 857660260
Labeler code: 85766
Product ID: 85766-260_5a6b02e7-eb2c-582e-e063-6294a90a8c1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Besifloxacin
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Sportpharm LLC
Application: NDA022308
Marketing category: NDA
Marketing start: 2026-01-09
Substance: BESIFLOXACIN
Active strength: 6 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
N022308-001	BESIVANCE	BESIFLOXACIN HYDROCHLORIDE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2009-05-28

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
N022308-001	8937062	2029-11-13	U-80		2015-02-03
N022308-001	8604020	2030-03-12		Drug product	2013-12-16
N022308-001	8415342	2030-11-07	U-80		2013-04-11
N022308-001	8481526	2031-01-09		Drug substance	2013-07-19

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 185 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	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`5bbf6a4d5a75…`

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: Besivance
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BESIFLOXACIN	6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BFE2NBZ7NX	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f312ddb2-3173-4c2c-bf1b-4ade8fb75d94	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Besivance	BESIFLOXACIN	Sportpharm LLC	f312ddb2-3173-4c2c-bf1b-4ade8fb75d94	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308 ndc (package): 85766-260-05 ndc (product): 85766-260 ndc11 (package): 85766026005
Besivance	BESIFLOXACIN	Sportpharm LLC	80bf4981-4f86-4d25-83a5-7d5dfe0b22e0	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308
Besivance	BESIFLOXACIN	Bausch & Lomb Americas Inc.	ff971287-5610-4f15-8392-fc974e6ff646	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308
Besivance	BESIFLOXACIN	Bausch & Lomb Incorporated	a3e6d688-7e5e-4ca3-b27e-79756c322a32	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BFE2NBZ7NX	BESIFLOXACIN	141388-76-3	BESIFLOXACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-260-05	85766026005	1 BOTTLE, DROPPER in 1 CARTON (85766-260-05) / 5 mL in 1 BOTTLE, DROPPER	2026-07-28	No	No	Current