NDC 71205-309

CIPRODEX

Ciprofloxacin And Dexamethasone

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

Product ID71205-309_3416c3a5-c4b5-456c-99af-d02d9d8fbbb6
NDC71205-309
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 NameProficient Rx LP
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 71205-309-75

1 BOTTLE, DROPPER in 1 CARTON (71205-309-75) > 7.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-309-75 [71205030975]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

OpenFDA Data

SPL SET ID:9b4466c2-bd57-49dd-8957-74f22f70e913
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403908
  • 404630

    • 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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