Search by Drug Name or NDC

    NDC 63629-8797-01 Ciprofloxacin and Dexamethasone 3; 1 mg/mL; mg/mL Details

    Ciprofloxacin and Dexamethasone 3; 1 mg/mL; mg/mL

    Ciprofloxacin and Dexamethasone is a AURICULAR (OTIC) SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE.

    Product Information

    NDC 63629-8797
    Product ID 63629-8797_1fdea66b-522b-440f-acbf-3c33727a7506
    Associated GPIs 87991002361820
    GCN Sequence Number 052911
    GCN Sequence Number Description ciprofloxacin HCl/dexameth DROPS SUSP 0.3 %-0.1% OTIC (EAR)
    HIC3 Q8F
    HIC3 Description OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS
    GCN 20188
    HICL Sequence Number 025488
    HICL Sequence Number Description CIPROFLOXACIN HCL/DEXAMETHASONE
    Brand/Generic Generic
    Proprietary Name Ciprofloxacin and Dexamethasone
    Proprietary Name Suffix n/a
    Non-Proprietary Name ciprofloxacin and dexamethasone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION/ DROPS
    Route AURICULAR (OTIC)
    Active Ingredient Strength 3; 1
    Active Ingredient Units mg/mL; mg/mL
    Substance Name CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
    DEA Schedule n/a
    Marketing Category NDA AUTHORIZED GENERIC
    Application Number NDA021537
    Listing Certified Through 2025-12-31

    Package

    NDC 63629-8797-01 (63629879701)

    NDC Package Code 63629-8797-1
    Billing NDC 63629879701
    Package 1 BOTTLE, DROPPER in 1 CARTON (63629-8797-1) / 7.5 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2021-09-10
    NDC Exclude Flag N
    Pricing Information N/A