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    NDC 71269-0040-10 Tuxarin 8; 54.3 mg/1; mg/1 Details

    Tuxarin 8; 54.3 mg/1; mg/1

    Tuxarin is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mainpointe Pharmaceuticals. The primary component is CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE.

    Product Information

    NDC 71269-0040
    Product ID 71269-040_e885499e-3423-4377-9f0e-0e315677a7b6
    Associated GPIs 43995202327430
    GCN Sequence Number 074339
    GCN Sequence Number Description chlorpheniramine/codeine phos TAB ER 12H 8MG-54.3MG ORAL
    HIC3 B4D
    HIC3 Description OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE
    GCN 38961
    HICL Sequence Number 000347
    HICL Sequence Number Description CHLORPHENIRAMINE MALEATE/CODEINE PHOSPHATE
    Brand/Generic Brand
    Proprietary Name Tuxarin
    Proprietary Name Suffix n/a
    Non-Proprietary Name codeine phosphate and chlorpheniramine maleate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 8; 54.3
    Active Ingredient Units mg/1; mg/1
    Substance Name CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
    Labeler Name Mainpointe Pharmaceuticals
    Pharmaceutical Class Full Opioid Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC]
    DEA Schedule CIII
    Marketing Category NDA
    Application Number NDA206323
    Listing Certified Through 2024-12-31

    Package

    NDC 71269-0040-10 (71269004010)

    NDC Package Code 71269-040-10
    Billing NDC 71269004010
    Package 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
    Marketing Start Date 2018-10-15
    NDC Exclude Flag N
    Pricing Information N/A