NDC 68071-1629

CIPRODEX

Ciprofloxacin And Dexamethasone

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

Product ID68071-1629_589c5d77-27e8-97d5-e053-2991aa0a5b7a
NDC68071-1629
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 NameNuCare Pharmaceuticals,Inc.
Substance NameCIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active Ingredient Strength3 mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1629-7

7.5 mL in 1 BOX (68071-1629-7)
Marketing Start Date2017-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1629-7 [68071162907]

CIPRODEX SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA021537
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-07

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

OpenFDA Data

SPL SET ID:589c5d77-27e7-97d5-e053-2991aa0a5b7a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403908
  • 404630

    • Pharmacological Class

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

    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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