NDC 0065-8533

CIPRODEX

Ciprofloxacin And Dexamethasone

CIPRODEX is a Auricular (otic) Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Ciprofloxacin Hydrochloride; Dexamethasone.

Product ID0065-8533_7f9e10f3-fa47-46ad-a689-1190f09714d2
NDC0065-8533
Product TypeHuman Prescription Drug
Proprietary NameCIPRODEX
Generic NameCiprofloxacin And Dexamethasone
Dosage FormSuspension/ Drops
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2003-08-04
Marketing CategoryNDA / NDA
Application NumberNDA021537
Labeler NameAlcon Laboratories, Inc.
Substance NameCIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active Ingredient Strength3 mg/mL; mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0065-8533-02

1 BOTTLE, DROPPER in 1 CARTON (0065-8533-02) > 7.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2003-08-04
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-8533-04 [00065853304]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-04

NDC 0065-8533-02 [00065853302]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-08-04

NDC 0065-8533-01 [00065853301]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-04
Marketing End Date2011-07-11

NDC 0065-8533-03 [00065853303]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-08-04

NDC 0065-8533-11 [00065853311]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-19

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

OpenFDA Data

SPL SET ID:0ed518de-4ae1-43d1-84ff-26872d9e6a0f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403908
  • 404630
    • UPC Code
  • 0300658533029

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "CIPRODEX" or generic name "Ciprofloxacin And Dexamethasone"

    NDCBrand NameGeneric Name
    0065-8533CIPRODEXciprofloxacin and dexamethasone
    0078-0799CIPRODEXciprofloxacin and dexamethasone
    21695-969CIPRODEXciprofloxacin and dexamethasone
    68071-1629CIPRODEXciprofloxacin and dexamethasone
    71205-309CIPRODEXciprofloxacin and dexamethasone
    0781-6186Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasone
    16714-628Ciprofloxacin and DexamethasoneCiprofloxacin and Dexamethasone
    43598-326Ciprofloxacin and DexamethasoneCiprofloxacin and Dexamethasone
    62756-427Ciprofloxacin and dexamethasoneCiprofloxacin and dexamethasone
    63629-8797Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasone

    Trademark Results [CIPRODEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CIPRODEX
    CIPRODEX
    75935885 2513415 Live/Registered
    Bayer Aktiengesellschaft
    2000-03-06
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