FDA.reportPublic FDA data

Ofloxacin Otic

Product NDC
60505-0363
11-digit product format
605050363
Labeler code
60505
Product ID
60505-0363_b1c42fcf-f4c3-117c-4fa2-7a68c821acd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Apotex Corp.
Application
ANDA076527
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 Otic
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
60505-0363-1Ofloxacin Otic5 mL in 1 BOTTLE, DROPPERSOLUTION59
60505-0363-2Ofloxacin Otic10 mL in 1 BOTTLE, DROPPERSOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0363-1ML - Milliliter60505-03638f1ac64d-1c59-4066-a076-274fa11d6cdb12012-07-24
60505-0363-2ML - Milliliter60505-03638b30d5b9-551f-4a4a-b531-a287e7cb673812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0363OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20241105_8db221b1-32f3-f6ca-e404-71f56a860d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSN567fa672-5fd0-4a1d-bc12-054a9ac16117106
242446ofloxacin 3 MG/ML Otic SolutionSCD567fa672-5fd0-4a1d-bc12-054a9ac16117106
242446ofloxacin 0.3 % Otic SolutionSY567fa672-5fd0-4a1d-bc12-054a9ac16117106
242446ofloxacin 0.3 % Otic SolutionPSN7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa100
242446ofloxacin 0.3 % Otic SolutionPSN4f4048b2-3ae8-441a-b1e3-7311fac00f94100
242446ofloxacin 3 MG/ML Otic SolutionSCD7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa100
242446ofloxacin 3 MG/ML Otic SolutionSCD4f4048b2-3ae8-441a-b1e3-7311fac00f94100
242446ofloxacin 0.3 % Otic SolutionSY7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa100
242446ofloxacin 0.3 % Otic SolutionSY4f4048b2-3ae8-441a-b1e3-7311fac00f94100
242446ofloxacin 0.3 % Otic SolutionPSN9d4b1225-e20d-4ace-850a-506fd031cac712
242446ofloxacin 3 MG/ML Otic SolutionSCD9d4b1225-e20d-4ace-850a-506fd031cac712
242446ofloxacin 0.3 % Otic SolutionSY9d4b1225-e20d-4ace-850a-506fd031cac712
242446ofloxacin 0.3 % Otic SolutionPSN8db221b1-32f3-f6ca-e404-71f56a860d089
242446ofloxacin 3 MG/ML Otic SolutionSCD8db221b1-32f3-f6ca-e404-71f56a860d089
242446ofloxacin 0.3 % Otic SolutionSY8db221b1-32f3-f6ca-e404-71f56a860d089
242446ofloxacin 0.3 % Otic SolutionPSN7592cf3f-7d4b-436f-89f0-a3686570fef85
242446ofloxacin 0.3 % Otic SolutionPSN76f461da-0e15-aa6d-e053-2a91aa0a98085
242446ofloxacin 3 MG/ML Otic SolutionSCD7592cf3f-7d4b-436f-89f0-a3686570fef85
242446ofloxacin 3 MG/ML Otic SolutionSCD76f461da-0e15-aa6d-e053-2a91aa0a98085
242446ofloxacin 0.3 % Otic SolutionSY7592cf3f-7d4b-436f-89f0-a3686570fef85
242446ofloxacin 0.3 % Otic SolutionSY76f461da-0e15-aa6d-e053-2a91aa0a98085
242446ofloxacin 0.3 % Otic SolutionPSNa7952956-b64a-0f99-e053-2995a90a0f914
242446ofloxacin 0.3 % Otic SolutionPSN79ef87c3-1f09-1625-e053-2991aa0a84ae4
242446ofloxacin 0.3 % Otic SolutionPSN14e6e355-3a87-43dc-80a2-070b9df93bf14
242446ofloxacin 3 MG/ML Otic SolutionSCD14e6e355-3a87-43dc-80a2-070b9df93bf14
242446ofloxacin 3 MG/ML Otic SolutionSCDa7952956-b64a-0f99-e053-2995a90a0f914
242446ofloxacin 3 MG/ML Otic SolutionSCD79ef87c3-1f09-1625-e053-2991aa0a84ae4
242446ofloxacin 0.3 % Otic SolutionSY79ef87c3-1f09-1625-e053-2991aa0a84ae4
242446ofloxacin 0.3 % Otic SolutionSYa7952956-b64a-0f99-e053-2995a90a0f914
242446ofloxacin 0.3 % Otic SolutionSY14e6e355-3a87-43dc-80a2-070b9df93bf14
242446ofloxacin 0.3 % Otic SolutionPSN42366170-e536-46a1-9735-d76e5820a9de3
242446ofloxacin 3 MG/ML Otic SolutionSCD42366170-e536-46a1-9735-d76e5820a9de3
242446ofloxacin 0.3 % Otic SolutionSY42366170-e536-46a1-9735-d76e5820a9de3
242446ofloxacin 0.3 % Otic SolutionPSN1b3cebc2-0079-2e29-e063-6394a90ae0fa1
242446ofloxacin 3 MG/ML Otic SolutionSCD1b3cebc2-0079-2e29-e063-6394a90ae0fa1
242446ofloxacin 0.3 % Otic SolutionSY1b3cebc2-0079-2e29-e063-6394a90ae0fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0363-1605050363015 mL in 1 BOTTLE, DROPPER (60505-0363-1) 5 ml2004-05-140000-00-00NoNoCurrent
60505-0363-26050503630210 mL in 1 BOTTLE, DROPPER (60505-0363-2) 10 ml2004-05-140000-00-00NoNoCurrent