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    NDC 71776-0035-01 Tobradex ST .5; 3 mg/mL; mg/mL Details

    Tobradex ST .5; 3 mg/mL; mg/mL

    Tobradex ST is a OPHTHALMIC SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eyevance Pharmaceuticals, LLC. The primary component is DEXAMETHASONE; TOBRAMYCIN.

    Product Information

    NDC 71776-0035
    Product ID 71776-035_07519d01-5c02-5671-e063-6294a90a25a8
    Associated GPIs 86309902801810
    GCN Sequence Number 066617
    GCN Sequence Number Description tobramycin/dexamethasone DROPS SUSP 0.3%-0.05% OPHTHALMIC
    HIC3 Q6I
    HIC3 Description EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS
    GCN 28944
    HICL Sequence Number 039399
    HICL Sequence Number Description TOBRAMYCIN/DEXAMETHASONE
    Brand/Generic Brand
    Proprietary Name Tobradex ST
    Proprietary Name Suffix n/a
    Non-Proprietary Name tobramycin / dexamethasone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION/ DROPS
    Route OPHTHALMIC
    Active Ingredient Strength .5; 3
    Active Ingredient Units mg/mL; mg/mL
    Substance Name DEXAMETHASONE; TOBRAMYCIN
    Labeler Name Eyevance Pharmaceuticals, LLC
    Pharmaceutical Class Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050818
    Listing Certified Through 2024-12-31

    Package

    NDC 71776-0035-01 (71776003501)

    NDC Package Code 71776-035-01
    Billing NDC 71776003501
    Package 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2021-05-19
    NDC Exclude Flag N
    Pricing Information N/A