FDA.reportPublic FDA data

Ofloxacin

Product NDC
17478-713
11-digit product format
174780713
Labeler code
17478
Product ID
17478-713_2ec72f20-1aee-406b-8ec5-57eba4808f58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA076407
Marketing category
ANDA
Marketing start
2008-07-01
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-713-102024-01-30C16284748780-11030e365-4dd0-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%
17478-713-112024-01-30C16284748780-11030e365-4dd0-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-713-10Ofloxacin1 in 1 CARTONSOLUTION/ DROPS19
17478-713-10Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS59
17478-713-11Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
17478-713-11Ofloxacin1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-713-10ML - Milliliter17478-7132e7c737f-2e47-4f3a-a9a2-c768d6183d2a12012-07-24
17478-713-11ML - Milliliter17478-71349da5e38-59f1-4699-82f7-887ff111fc6612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
WaterINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
OfloxacinACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [AKORN, INC.]2
OfloxacinACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-713OFLOXACIN SOLUTION/ DROPS [AKORN]9Legacy NDC, 4 package rows20220916_8b73d354-4631-40e8-b187-e8b0580bd6ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN8b73d354-4631-40e8-b187-e8b0580bd6ea9
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD8b73d354-4631-40e8-b187-e8b0580bd6ea9
312075ofloxacin 0.3 % Ophthalmic SolutionSY8b73d354-4631-40e8-b187-e8b0580bd6ea9
312075ofloxacin 0.3 % Ophthalmic SolutionPSN51f3d155-36df-4c40-e054-00144ff8d46c6
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD51f3d155-36df-4c40-e054-00144ff8d46c6
312075ofloxacin 0.3 % Ophthalmic SolutionSY51f3d155-36df-4c40-e054-00144ff8d46c6
312075ofloxacin 0.3 % Ophthalmic SolutionPSN2d2807a8-19d5-4922-8270-a8885d61e8514
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD2d2807a8-19d5-4922-8270-a8885d61e8514
312075ofloxacin 0.3 % Ophthalmic SolutionSY2d2807a8-19d5-4922-8270-a8885d61e8514
312075ofloxacin 0.3 % Ophthalmic SolutionPSNbed09b0a-774b-414e-b253-a0ff5f0685a03
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDbed09b0a-774b-414e-b253-a0ff5f0685a03
312075ofloxacin 0.3 % Ophthalmic SolutionSYbed09b0a-774b-414e-b253-a0ff5f0685a03
312075ofloxacin 0.3 % Ophthalmic SolutionPSN71ed7493-f4b2-4e6e-a66c-19740bc7bbd22
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD71ed7493-f4b2-4e6e-a66c-19740bc7bbd22
312075ofloxacin 0.3 % Ophthalmic SolutionSY71ed7493-f4b2-4e6e-a66c-19740bc7bbd22
312075ofloxacin 0.3 % Ophthalmic SolutionPSNef54fd2a-df62-ba37-e053-2a95a90aafb71
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDef54fd2a-df62-ba37-e053-2a95a90aafb71
312075ofloxacin 0.3 % Ophthalmic SolutionSYef54fd2a-df62-ba37-e053-2a95a90aafb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-713-10174780713101 BOTTLE, DROPPER in 1 CARTON (17478-713-10) > 5 mL in 1 BOTTLE, DROPPER2008-07-010000-00-00NoNoCurrent
17478-713-11174780713111 BOTTLE, DROPPER in 1 CARTON (17478-713-11) > 10 mL in 1 BOTTLE, DROPPER2008-07-010000-00-00NoNoCurrent