FDA.reportPublic FDA data

Ofloxacin

Product NDC
24208-410
11-digit product format
242080410
Labeler code
24208
Product ID
24208-410_3f88eb9b-9978-4379-b034-92c45b6c259c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Bausch & Lomb Incorporated
Application
ANDA076128
Marketing category
ANDA
Marketing start
2008-03-17
Substance
OFLOXACIN
Active strength
3 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
Ofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui242446

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-410-05Ofloxacin1 in 1 CARTONSOLUTION113
24208-410-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION513
24208-410-10Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION1013
24208-410-10Ofloxacin1 in 1 CARTONSOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-410-05ML - Milliliter24208-4106dfaf866-ed4b-44e3-bdcb-23241d1aac4d12012-07-24
24208-410-10ML - Milliliter24208-410cb840692-c422-4f7f-9ca9-8f6e165f3ff112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]8
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [PROFICIENT RX LP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-410OFLOXACIN SOLUTION [BAUSCH & LOMB INCORPORATED]13Current NDC, Legacy NDC, 4 package rows20230712_c5484f1a-2321-453f-9469-dfcf709e2e2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSNc5484f1a-2321-453f-9469-dfcf709e2e2e13
242446ofloxacin 3 MG/ML Otic SolutionSCDc5484f1a-2321-453f-9469-dfcf709e2e2e13
242446ofloxacin 0.3 % Otic SolutionSYc5484f1a-2321-453f-9469-dfcf709e2e2e13
242446ofloxacin 0.3 % Otic SolutionPSN0c5bb891-b3db-4f9c-8392-4aed6e74b1a75
242446ofloxacin 0.3 % Otic SolutionPSNbfe09726-9acb-4032-be91-ef2614662ae25
242446ofloxacin 3 MG/ML Otic SolutionSCD0c5bb891-b3db-4f9c-8392-4aed6e74b1a75
242446ofloxacin 3 MG/ML Otic SolutionSCDbfe09726-9acb-4032-be91-ef2614662ae25
242446ofloxacin 0.3 % Otic SolutionSY0c5bb891-b3db-4f9c-8392-4aed6e74b1a75
242446ofloxacin 0.3 % Otic SolutionSYbfe09726-9acb-4032-be91-ef2614662ae25
242446ofloxacin 0.3 % Otic SolutionPSN2fbd51a5-462c-4741-e063-6394a90a0d873
242446ofloxacin 3 MG/ML Otic SolutionSCD2fbd51a5-462c-4741-e063-6394a90a0d873
242446ofloxacin 0.3 % Otic SolutionSY2fbd51a5-462c-4741-e063-6394a90a0d873
242446ofloxacin 0.3 % Otic SolutionPSNa522f324-70a0-4051-830b-57a658c1e0651
242446ofloxacin 0.3 % Otic SolutionPSNd02d88ba-1c90-4f82-bc94-4ad3c9918cb11
242446ofloxacin 3 MG/ML Otic SolutionSCDa522f324-70a0-4051-830b-57a658c1e0651
242446ofloxacin 3 MG/ML Otic SolutionSCDd02d88ba-1c90-4f82-bc94-4ad3c9918cb11
242446ofloxacin 0.3 % Otic SolutionSYa522f324-70a0-4051-830b-57a658c1e0651
242446ofloxacin 0.3 % Otic SolutionSYd02d88ba-1c90-4f82-bc94-4ad3c9918cb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-410-05242080410051 BOTTLE, DROPPER in 1 CARTON (24208-410-05) / 5 mL in 1 BOTTLE, DROPPER2008-03-170000-00-00NoNoCurrent
24208-410-10242080410101 BOTTLE, DROPPER in 1 CARTON (24208-410-10) / 10 mL in 1 BOTTLE, DROPPER2008-03-170000-00-00NoNoCurrent