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    NDC 59212-0422-10 Donnatal .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Details

    Donnatal .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL

    Donnatal is a ORAL ELIXIR in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE.

    Product Information

    NDC 59212-0422
    Product ID 59212-422_1bac18c3-7e0c-4391-a763-479b6e26b960
    Associated GPIs 49109904051030
    GCN Sequence Number 004773
    GCN Sequence Number Description phenobarb/hyoscy/atropine/scop ELIXIR 16.2MG/5ML ORAL
    HIC3 J2A
    HIC3 Description BELLADONNA ALKALOIDS
    GCN 74040
    HICL Sequence Number 035019
    HICL Sequence Number Description PHENOBARBITAL/HYOSCYAMINE SULF/ATROPINE SULF/SCOPOLAMINE HB
    Brand/Generic Brand
    Proprietary Name Donnatal
    Proprietary Name Suffix n/a
    Non-Proprietary Name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form ELIXIR
    Route ORAL
    Active Ingredient Strength .0194; .1037; 16.2; .0065
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL; mg/5mL
    Substance Name ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
    Labeler Name Concordia Pharmaceuticals Inc.
    Pharmaceutical Class Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
    DEA Schedule CIV
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2024-12-31

    Package

    NDC 59212-0422-10 (59212042210)

    NDC Package Code 59212-422-10
    Billing NDC 59212042210
    Package 10 mL in 1 BOTTLE (59212-422-10)
    Marketing Start Date 1980-12-30
    NDC Exclude Flag N
    Pricing Information N/A