NDC 66992-450

CETRAXAL

Ciprofloxacin

CETRAXAL is a Auricular (otic) Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Wraser Llc. The primary component is Ciprofloxacin Hydrochloride.

Product ID66992-450_ca024935-ff23-4a29-8d2a-8337938d5808
NDC66992-450
Product TypeHuman Prescription Drug
Proprietary NameCETRAXAL
Generic NameCiprofloxacin
Dosage FormSolution/ Drops
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2009-05-14
Marketing CategoryNDA / NDA
Application NumberNDA021918
Labeler NameWraser Llc
Substance NameCIPROFLOXACIN HYDROCHLORIDE
Active Ingredient Strength1 mg/.25mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 66992-450-14

14 CONTAINER in 1 CARTON (66992-450-14) > .25 mL in 1 CONTAINER
Marketing Start Date2009-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66992-450-14 [66992045014]

CETRAXAL SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA021918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-14

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE.5 mg/.25mL

OpenFDA Data

SPL SET ID:213b339a-75e0-4b1d-9052-8ee82a65d713
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848960
  • 848956

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]
    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    NDC Crossover Matching brand name "CETRAXAL" or generic name "Ciprofloxacin"

    NDCBrand NameGeneric Name
    66992-450CETRAXALCETRAXAL
    0143-2037CiprofloxacinCiprofloxacin
    0143-9927CiprofloxacinCiprofloxacin
    0143-9928CiprofloxacinCiprofloxacin
    0143-9929CiprofloxacinCiprofloxacin
    0172-5312CiprofloxacinCiprofloxacin
    0179-0188CiprofloxacinCiprofloxacin
    0378-1743Ciprofloxacinciprofloxacin
    0378-1745Ciprofloxacinciprofloxacin
    0378-7098Ciprofloxacinciprofloxacin
    0409-4777CIPROFLOXACINCIPROFLOXACIN
    0615-8147CiprofloxacinCiprofloxacin
    0615-8367CiprofloxacinCiprofloxacin
    0781-3239CiprofloxacinCiprofloxacin
    0409-2300Ciprofloxacin in Dextroseciprofloxacin
    0409-3300Ciprofloxacin in Dextroseciprofloxacin

    Trademark Results [CETRAXAL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CETRAXAL
    CETRAXAL
    76567218 2963725 Live/Registered
    LABORATORIOS SALVAT, S.A.
    2003-12-24
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.