FDA.reportPublic FDA data

Besivance

Product NDC
24208-446
11-digit product format
242080446
Labeler code
24208
Product ID
24208-446_1c4756f2-d92f-af5d-e063-6294a90a9a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Besifloxacin
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA022308
Marketing category
NDA
Marketing start
2009-05-28
Substance
BESIFLOXACIN
Active strength
6 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Besivance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BESIFLOXACIN6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBFE2NBZ7NX
Rxcui850305, 850309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24208-446-022020-08-13C16284748780-1ab0e2407-2d96-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BESIVANCE safely and effectively. See full prescribing information for BESIVANCE. BESIVANCE ® (besifloxacin ophthalmic suspension), for topical ophthalmic use Initial U.S. Approval: 2009
24208-446-052020-08-13C16284748780-1ab0e2407-2d96-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BESIVANCE safely and effectively. See full prescribing information for BESIVANCE. BESIVANCE ® (besifloxacin ophthalmic suspension), for topical ophthalmic use Initial U.S. Approval: 2009
24208-446-022020-07-22C16284748780-1ab0e2407-2d96-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BESIVANCE safely and effectively. See full prescribing information for BESIVANCE. BESIVANCE ® (besifloxacin ophthalmic suspension), for topical ophthalmic use Initial U.S. Approval: 2009
24208-446-052020-07-22C16284748780-1ab0e2407-2d96-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BESIVANCE safely and effectively. See full prescribing information for BESIVANCE. BESIVANCE ® (besifloxacin ophthalmic suspension), for topical ophthalmic use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-446-02Besivance2 mL in 1 BOTTLE, DROPPERSUSPENSION220
24208-446-02Besivance1 in 1 CARTONSUSPENSION120
24208-446-05Besivance1 in 1 CARTONSUSPENSION120
24208-446-05Besivance5 mL in 1 BOTTLE, DROPPERSUSPENSION520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-446BESIVANCE (BESIFLOXACIN) SUSPENSION [BAUSCH & LOMB INCORPORATED]20Current NDC, Legacy NDC, 4 package rows20240704_a3e6d688-7e5e-4ca3-b27e-79756c322a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850305besifloxacin 0.6 % Ophthalmic SuspensionPSNa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850309Besivance 0.6 % Ophthalmic SuspensionPSNa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850309besifloxacin 6 MG/ML Ophthalmic Suspension [Besivance]SBDa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850305besifloxacin 6 MG/ML Ophthalmic SuspensionSCDa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850305besifloxacin 0.6 % Ophthalmic SuspensionSYa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850309Besivance 0.6 % Ophthalmic SuspensionSYa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850309Besivance 6 MG/ML Ophthalmic SuspensionSYa3e6d688-7e5e-4ca3-b27e-79756c322a3220
850305besifloxacin 0.6 % Ophthalmic SuspensionPSNc326263e-4b55-41b6-b862-c970668669ec1
850309Besivance 0.6 % Ophthalmic SuspensionPSNc326263e-4b55-41b6-b862-c970668669ec1
850309besifloxacin 6 MG/ML Ophthalmic Suspension [Besivance]SBDc326263e-4b55-41b6-b862-c970668669ec1
850305besifloxacin 6 MG/ML Ophthalmic SuspensionSCDc326263e-4b55-41b6-b862-c970668669ec1
850305besifloxacin 0.6 % Ophthalmic SuspensionSYc326263e-4b55-41b6-b862-c970668669ec1
850309Besivance 0.6 % Ophthalmic SuspensionSYc326263e-4b55-41b6-b862-c970668669ec1
850309Besivance 6 MG/ML Ophthalmic SuspensionSYc326263e-4b55-41b6-b862-c970668669ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-446-02242080446021 BOTTLE, DROPPER in 1 CARTON (24208-446-02) / 2 mL in 1 BOTTLE, DROPPER2009-05-280000-00-00NoNoCurrent
24208-446-05242080446051 BOTTLE, DROPPER in 1 CARTON (24208-446-05) / 5 mL in 1 BOTTLE, DROPPER2009-05-280000-00-00NoNoCurrent