NDC 69251-201

Otiprio

Ciprofloxacin

Otiprio is a Intratympanic Suspension in the Human Prescription Drug category. It is labeled and distributed by Otonomy, Inc.. The primary component is Ciprofloxacin.

Product ID69251-201_44d2ab10-db38-11ea-8b6e-0800200c9a66
NDC69251-201
Product TypeHuman Prescription Drug
Proprietary NameOtiprio
Generic NameCiprofloxacin
Dosage FormSuspension
Route of AdministrationINTRATYMPANIC
Marketing Start Date2016-02-11
Marketing CategoryNDA / NDA
Application NumberNDA207986
Labeler NameOtonomy, Inc.
Substance NameCIPROFLOXACIN
Active Ingredient Strength6 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69251-201-01

1 VIAL, SINGLE-USE in 1 CARTON (69251-201-01) > 1 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2016-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69251-201-01 [69251020101]

Otiprio SUSPENSION
Marketing CategoryNDA
Application NumberNDA207986
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN6 mg/mL

OpenFDA Data

SPL SET ID:8365e37a-0b35-497c-aab4-f25053378154
Manufacturer
UNII
UPC Code
  • 0369251201018

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

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

    NDCBrand NameGeneric Name
    0268-8200OTIPRIOOTIPRIO
    69251-201OtiprioOtiprio
    0143-2037CiprofloxacinCiprofloxacin
    0143-9927CiprofloxacinCiprofloxacin
    0143-9928CiprofloxacinCiprofloxacin
    0143-9929CiprofloxacinCiprofloxacin
    0172-5312CiprofloxacinCiprofloxacin
    0179-0188CiprofloxacinCiprofloxacin
    0378-1743Ciprofloxacinciprofloxacin
    0378-1745Ciprofloxacinciprofloxacin
    0378-7098Ciprofloxacinciprofloxacin
    0409-4777CIPROFLOXACINCIPROFLOXACIN
    0615-8147CiprofloxacinCiprofloxacin
    0615-8367CiprofloxacinCiprofloxacin
    0409-2300Ciprofloxacin in Dextroseciprofloxacin
    0409-3300Ciprofloxacin in Dextroseciprofloxacin

    Trademark Results [Otiprio]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OTIPRIO
    OTIPRIO
    86590273 5013864 Live/Registered
    Otonomy, Inc.
    2015-04-07
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