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    NDC 82111-0518-01 DARTISLA ODT 1.7 mg/1 Details

    DARTISLA ODT 1.7 mg/1

    DARTISLA ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Edenbridge Pharmaceuticals LLC.. The primary component is GLYCOPYRROLATE.

    Product Information

    NDC 82111-0518
    Product ID 82111-518_b7fa57f9-9e30-4011-8e80-d2e5699d5b6a
    Associated GPIs 49102030007220
    GCN Sequence Number 082932
    GCN Sequence Number Description glycopyrrolate TAB RAPDIS 1.7 MG ORAL
    HIC3 J2B
    HIC3 Description ANTICHOLINERGICS,QUATERNARY AMMONIUM
    GCN 51729
    HICL Sequence Number 002028
    HICL Sequence Number Description GLYCOPYRROLATE
    Brand/Generic Brand
    Proprietary Name DARTISLA ODT
    Proprietary Name Suffix n/a
    Non-Proprietary Name Glycopyrrolate Orally Disintegrating Tablets
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, ORALLY DISINTEGRATING
    Route ORAL
    Active Ingredient Strength 1.7
    Active Ingredient Units mg/1
    Substance Name GLYCOPYRROLATE
    Labeler Name Edenbridge Pharmaceuticals LLC.
    Pharmaceutical Class Anticholinergic [EPC], Cholinergic Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA215019
    Listing Certified Through 2022-12-31

    Package

    NDC 82111-0518-01 (82111051801)

    NDC Package Code 82111-518-01
    Billing NDC 82111051801
    Package 3 BLISTER PACK in 1 CARTON (82111-518-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
    Marketing Start Date 2022-02-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 52daf47e-7ba3-4105-be7f-27001a87e16e Details

    Revised: 12/2021