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    NDC 00065-0397-02 Cyclogyl 20 mg/mL Details

    Cyclogyl 20 mg/mL

    Cyclogyl is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is CYCLOPENTOLATE HYDROCHLORIDE.

    Product Information

    NDC 00065-0397
    Product ID 0065-0397_0aa45ce5-d393-4030-aab5-ff5073c42381
    Associated GPIs 86350020102015
    GCN Sequence Number 007876
    GCN Sequence Number Description cyclopentolate HCl DROPS 2 % OPHTHALMIC
    HIC3 Q6J
    HIC3 Description MYDRIATICS
    GCN 33032
    HICL Sequence Number 003467
    HICL Sequence Number Description CYCLOPENTOLATE HCL
    Brand/Generic Brand
    Proprietary Name Cyclogyl
    Proprietary Name Suffix n/a
    Non-Proprietary Name cyclopentolate hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION/ DROPS
    Route OPHTHALMIC
    Active Ingredient Strength 20
    Active Ingredient Units mg/mL
    Substance Name CYCLOPENTOLATE HYDROCHLORIDE
    Labeler Name Alcon Laboratories, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA084108
    Listing Certified Through 2024-12-31

    Package

    NDC 00065-0397-02 (00065039702)

    NDC Package Code 0065-0397-02
    Billing NDC 00065039702
    Package 1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTIC
    Marketing Start Date 1975-10-15
    NDC Exclude Flag N
    Pricing Information N/A