FDA.reportPublic FDA data

CETRAXAL

Product NDC
66992-450
11-digit product format
669920450
Labeler code
66992
Product ID
66992-450_ca024935-ff23-4a29-8d2a-8337938d5808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Wraser Llc
Application
NDA021918
Marketing category
NDA
Marketing start
2009-05-14
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
1 mg/.25mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66992-450-142024-04-21C16284748780-1ba0f9c33-3969-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-142024-01-30C16284748780-1ba0f9c33-3969-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-142021-02-02C16284748780-1ba0f9c33-3969-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987
66992-450-142021-01-29C16284748780-1ba0f9c33-3969-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Cetraxal safely and effectively. See full prescribing information for Cetraxal. Cetraxal (Ciprofloxacin otic solution) 0.2% Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66992-450-14CETRAXAL14 in 1 CARTONSOLUTION/ DROPS148
66992-450-14CETRAXAL0.25 mL in 1 CONTAINERSOLUTION/ DROPS0.258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66992-450-14EA - Each66992-4507e048e6b-5251-4106-aa7d-a2e0b884c75e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CiprofloxacinACTIVE INGREDIENT5E8K9I0O4UCETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
CiprofloxacinACTIVE MOIETY5E8K9I0O4UCETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
lactic acidINACTIVE INGREDIENT33X04XA5ATCETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
povidoneINACTIVE INGREDIENTFZ989GH94ECETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ICETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RCETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66992-450CETRAXAL (CIPROFLOXACIN) SOLUTION/ DROPS [WRASER LLC]8Legacy NDC, 2 package rows20241011_213b339a-75e0-4b1d-9052-8ee82a65d713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848960Cetraxal 0.2 % Otic SolutionPSN213b339a-75e0-4b1d-9052-8ee82a65d7138
848956ciprofloxacin HCl 0.2 % Otic SolutionPSN213b339a-75e0-4b1d-9052-8ee82a65d7138
848960ciprofloxacin 2 MG/ML Otic Solution [Cetraxal]SBD213b339a-75e0-4b1d-9052-8ee82a65d7138
848956ciprofloxacin 2 MG/ML Otic SolutionSCD213b339a-75e0-4b1d-9052-8ee82a65d7138
848960Cetraxal 0.2 % (as ciprofloxacin HCl) Otic SolutionSY213b339a-75e0-4b1d-9052-8ee82a65d7138
848960Cetraxal 0.2 % Otic SolutionSY213b339a-75e0-4b1d-9052-8ee82a65d7138
848960Cetraxal 2 MG/ML Otic SolutionSY213b339a-75e0-4b1d-9052-8ee82a65d7138
848956ciprofloxacin 0.2 % Otic SolutionSY213b339a-75e0-4b1d-9052-8ee82a65d7138

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66992-450-146699204501414 CONTAINER in 1 CARTON (66992-450-14) > .25 mL in 1 CONTAINER14 container2009-05-140000-00-00NoNoCurrent