Ofloxacin

Product NDC
63187-472
11-digit product format
631870472
Labeler code
63187
Product ID
63187-472_adddd480-d3b1-4497-8bad-b5c55c2bb8bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Proficient Rx LP
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
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-472-05Ofloxacin1 in 1 CARTONSOLUTION15
63187-472-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION55

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-472OFLOXACIN SOLUTION [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20220730_bfe09726-9acb-4032-be91-ef2614662ae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSNbfe09726-9acb-4032-be91-ef2614662ae25
242446ofloxacin 3 MG/ML Otic SolutionSCDbfe09726-9acb-4032-be91-ef2614662ae25
242446ofloxacin 0.3 % Otic SolutionSYbfe09726-9acb-4032-be91-ef2614662ae25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-472-05631870472051 BOTTLE, DROPPER in 1 CARTON (63187-472-05) / 5 mL in 1 BOTTLE, DROPPER2015-02-020000-00-00NoNoCurrent