OCUFLOX

Product NDC
11980-779
11-digit product format
119800779
Labeler code
11980
Product ID
11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA019921
Marketing category
NDA
Marketing start
1993-08-01
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
OCUFLOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui207202, 312075

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11980-779-05OCUFLOX5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS513
11980-779-05OCUFLOX1 in 1 CARTONSOLUTION/ DROPS113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11980-779-05ML - Milliliter11980-7796832efe3-38b6-4943-b84f-cea44157223b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ofloxacinACTIVE INGREDIENTA4P49JAZ9HOCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
ofloxacinACTIVE MOIETYA4P49JAZ9HOCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7OCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
hydrochloric acidINACTIVE INGREDIENTQTT17582CBOCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XOCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
waterINACTIVE INGREDIENT059QF0KO0ROCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11980-779OCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]13Current NDC, Legacy NDC, 2 package rows20250109_7aab4449-3dda-4e2c-8e40-b3244a548bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207202Ocuflox 0.3 % Ophthalmic SolutionPSN7aab4449-3dda-4e2c-8e40-b3244a548bf513
312075ofloxacin 0.3 % Ophthalmic SolutionPSN7aab4449-3dda-4e2c-8e40-b3244a548bf513
207202ofloxacin 3 MG/ML Ophthalmic Solution [Ocuflox]SBD7aab4449-3dda-4e2c-8e40-b3244a548bf513
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD7aab4449-3dda-4e2c-8e40-b3244a548bf513
207202Ocuflox 0.3 % Ophthalmic SolutionSY7aab4449-3dda-4e2c-8e40-b3244a548bf513
207202Ocuflox 3 MG/ML Ophthalmic SolutionSY7aab4449-3dda-4e2c-8e40-b3244a548bf513
312075ofloxacin 0.3 % Ophthalmic SolutionSY7aab4449-3dda-4e2c-8e40-b3244a548bf513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11980-779-05119800779051 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER1993-08-010000-00-00NoNoCurrent