NDC 42195-550

Ciprofloxacin Otic

Ciprofloxacin

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

Product ID42195-550_613cf17e-578a-4530-ac73-179d72a9e415
NDC42195-550
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin Otic
Generic NameCiprofloxacin
Dosage FormSolution/ Drops
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2012-08-27
Marketing CategoryNDA / NDA
Application NumberNDA021918
Labeler NameXspire Pharma, 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 42195-550-14

14 CONTAINER in 1 CARTON (42195-550-14) > .25 mL in 1 CONTAINER
Marketing Start Date2012-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42195-550-14 [42195055014]

Ciprofloxacin Otic SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA021918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-27

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE.5 mg/.25mL

OpenFDA Data

SPL SET ID:d0125acf-1879-452d-ba29-c0f753653789
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848956

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    Medicade Reported Pricing

    42195055014 CIPROFLOXACIN 0.2% OTIC SOLN

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    42195-550Ciprofloxacin OticCiprofloxacin Otic
    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
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