Ofloxacin

Product NDC
24208-434
11-digit product format
242080434
Labeler code
24208
Product ID
24208-434_37639b58-1d0f-206e-e063-6294a90a293a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA076622
Marketing category
ANDA
Marketing start
2004-05-14
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
Rxcui312075

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
24208-434-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS514
24208-434-05Ofloxacin1 in 1 CARTONSOLUTION/ DROPS114
24208-434-10Ofloxacin1 in 1 CARTONSOLUTION/ DROPS114
24208-434-10Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-434-05ML - Milliliter24208-43417a52039-d648-42ee-9f71-f3d2e784e49612012-07-24
24208-434-10ML - Milliliter24208-4341b91eac8-3177-4419-bd84-f24ce2123bfc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]2
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-434OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]13Current NDC, Legacy NDC, 4 package rows20230630_ad40954d-0b1d-47c5-8bd5-8a1efd9a7153.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNad40954d-0b1d-47c5-8bd5-8a1efd9a715314
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDad40954d-0b1d-47c5-8bd5-8a1efd9a715314
312075ofloxacin 0.3 % Ophthalmic SolutionSYad40954d-0b1d-47c5-8bd5-8a1efd9a715314
312075ofloxacin 0.3 % Ophthalmic SolutionPSN0c01de7a-a885-4bf0-8df0-7c62170b78506
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD0c01de7a-a885-4bf0-8df0-7c62170b78506
312075ofloxacin 0.3 % Ophthalmic SolutionSY0c01de7a-a885-4bf0-8df0-7c62170b78506
312075ofloxacin 0.3 % Ophthalmic SolutionPSNff88214e-19b5-428d-a10d-91c3edc89a665
312075ofloxacin 0.3 % Ophthalmic SolutionPSNc8020ad4-ac74-4ceb-863e-94da605cf23f5
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDff88214e-19b5-428d-a10d-91c3edc89a665
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDc8020ad4-ac74-4ceb-863e-94da605cf23f5
312075ofloxacin 0.3 % Ophthalmic SolutionSYff88214e-19b5-428d-a10d-91c3edc89a665
312075ofloxacin 0.3 % Ophthalmic SolutionSYc8020ad4-ac74-4ceb-863e-94da605cf23f5
312075ofloxacin 0.3 % Ophthalmic SolutionPSN1f42711d-f960-4832-acf5-97096aa6ad774
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD1f42711d-f960-4832-acf5-97096aa6ad774
312075ofloxacin 0.3 % Ophthalmic SolutionSY1f42711d-f960-4832-acf5-97096aa6ad774
312075ofloxacin 0.3 % Ophthalmic SolutionPSNaf861f20-5ec8-2883-e053-2a95a90a23123
312075ofloxacin 0.3 % Ophthalmic SolutionPSNae6b5cb0-aa18-a6d2-e053-2995a90a525d3
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDae6b5cb0-aa18-a6d2-e053-2995a90a525d3
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDaf861f20-5ec8-2883-e053-2a95a90a23123
312075ofloxacin 0.3 % Ophthalmic SolutionSYae6b5cb0-aa18-a6d2-e053-2995a90a525d3
312075ofloxacin 0.3 % Ophthalmic SolutionSYaf861f20-5ec8-2883-e053-2a95a90a23123
312075ofloxacin 0.3 % Ophthalmic SolutionPSN1838671d-e312-442a-b0bc-6702d6a8965c1
312075ofloxacin 0.3 % Ophthalmic SolutionPSN7bfa54ff-9a72-45e1-8fe5-e8411f8c6e711
312075ofloxacin 0.3 % Ophthalmic SolutionPSN1d53674a-1377-ce2b-e063-6394a90a526f1
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD1d53674a-1377-ce2b-e063-6394a90a526f1
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD1838671d-e312-442a-b0bc-6702d6a8965c1
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD7bfa54ff-9a72-45e1-8fe5-e8411f8c6e711
312075ofloxacin 0.3 % Ophthalmic SolutionSY1838671d-e312-442a-b0bc-6702d6a8965c1
312075ofloxacin 0.3 % Ophthalmic SolutionSY7bfa54ff-9a72-45e1-8fe5-e8411f8c6e711
312075ofloxacin 0.3 % Ophthalmic SolutionSY1d53674a-1377-ce2b-e063-6394a90a526f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-434-05242080434051 BOTTLE, DROPPER in 1 CARTON (24208-434-05) / 5 mL in 1 BOTTLE, DROPPER2004-05-140000-00-00NoNoCurrent
24208-434-10242080434101 BOTTLE, DROPPER in 1 CARTON (24208-434-10) / 10 mL in 1 BOTTLE, DROPPER2004-05-140000-00-00NoNoCurrent