Search by Drug Name or NDC

    NDC 59212-0425-10 Donnatal .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Details

    Donnatal .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1

    Donnatal is a ORAL TABLET 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 59212-0425
    Product ID 59212-425_29d98e6b-05f6-4719-bda4-66d681279738
    Associated GPIs 49109904050320
    GCN Sequence Number 004777
    GCN Sequence Number Description phenobarb/hyoscy/atropine/scop TABLET 16.2 MG ORAL
    HIC3 J2A
    HIC3 Description BELLADONNA ALKALOIDS
    GCN 74070
    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 TABLET
    Route ORAL
    Active Ingredient Strength .0194; .1037; 16.2; .0065
    Active Ingredient Units mg/1; mg/1; mg/1; mg/1
    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 59212-0425-10 (59212042510)

    NDC Package Code 59212-425-10
    Billing NDC 59212042510
    Package 100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)
    Marketing Start Date 1980-12-30
    NDC Exclude Flag N
    Pricing Information N/A