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    NDC 75826-0107-11 Diphenoxylate Hydrochloride and Atropine Sulfate .025; 2.5 mg/1; mg/1 Details

    Diphenoxylate Hydrochloride and Atropine Sulfate .025; 2.5 mg/1; mg/1

    Diphenoxylate Hydrochloride and Atropine Sulfate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Winder Laboratories LLC. The primary component is ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE.

    Product Information

    NDC 75826-0107
    Product ID 75826-107_e764053d-4fd1-ea36-e053-2995a90a4ea9
    Associated GPIs 47100010100310
    GCN Sequence Number 002841
    GCN Sequence Number Description diphenoxylate HCl/atropine TABLET 2.5-.025MG ORAL
    HIC3 D6D
    HIC3 Description ANTIDIARRHEALS
    GCN 65030
    HICL Sequence Number 001235
    HICL Sequence Number Description DIPHENOXYLATE HCL/ATROPINE SULFATE
    Brand/Generic Generic
    Proprietary Name Diphenoxylate Hydrochloride and Atropine Sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Diphenoxylate Hydrochloride and Atropine Sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength .025; 2.5
    Active Ingredient Units mg/1; mg/1
    Substance Name ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
    Labeler Name Winder Laboratories LLC
    Pharmaceutical Class Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA211362
    Listing Certified Through 2024-12-31

    Package

    NDC 75826-0107-11 (75826010711)

    NDC Package Code 75826-107-11
    Billing NDC 75826010711
    Package 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11)
    Marketing Start Date 2022-09-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 7344a2d2-1f8a-4c5a-90e3-181b919c0c7a Details

    Revised: 5/2022