FDA.reportPublic FDA data

Ofloxacin

Product NDC
42254-257
11-digit product format
422540257
Labeler code
42254
Product ID
42254-257_a522f324-70a0-4051-830b-57a658c1e065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Rebel Distributors Corp
Application
ANDA076128
Marketing category
ANDA
Marketing start
2008-03-17
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
42254-257-052019-09-24C16284748780-19350213a-3d34-c013-e053-90daa90a1393Ofloxacin Otic Solution 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-257-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION51
42254-257-05Ofloxacin1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-257-05ML - Milliliter42254-257ac574f51-1cbb-4b47-bfaa-3e5f6067c8cb12013-04-01

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-257OFLOXACIN SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130329_a522f324-70a0-4051-830b-57a658c1e065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSNa522f324-70a0-4051-830b-57a658c1e0651
242446ofloxacin 3 MG/ML Otic SolutionSCDa522f324-70a0-4051-830b-57a658c1e0651
242446ofloxacin 0.3 % Otic SolutionSYa522f324-70a0-4051-830b-57a658c1e0651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-257-05422540257055 mL in 1 BOTTLE, DROPPER5 mlHistorical