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    NDC 17478-0097-10 Cyclopentolate Hydrochloride 20 mg/mL Details

    Cyclopentolate Hydrochloride 20 mg/mL

    Cyclopentolate Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is CYCLOPENTOLATE HYDROCHLORIDE.

    Product Information

    NDC 17478-0097
    Product ID 17478-097_d9736f0b-8fb3-44ff-aca7-b35c20538c50
    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 Generic
    Proprietary Name Cyclopentolate Hydrochloride
    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 Akorn
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040165
    Listing Certified Through 2024-12-31

    Package

    NDC 17478-0097-10 (17478009710)

    NDC Package Code 17478-097-10
    Billing NDC 17478009710
    Package 1 BOTTLE, DROPPER in 1 CARTON (17478-097-10) / 5 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 1997-01-13
    NDC Exclude Flag N
    Pricing Information N/A