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    NDC 61269-0385-12 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Details

    BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1

    BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by H2-Pharma, LLC. The primary component is BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE.

    Product Information

    NDC 61269-0385
    Product ID 61269-385_5bf2f641-254d-484c-9970-3f8729c7aff7
    Associated GPIs
    GCN Sequence Number 062462
    GCN Sequence Number Description bismuth/metronid/tetracycline CAPSULE 125-125 MG ORAL
    HIC3 D4F
    HIC3 Description ANTI-ULCER-H.PYLORI AGENTS
    GCN 98238
    HICL Sequence Number 020019
    HICL Sequence Number Description COLLOIDAL BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE HCL
    Brand/Generic Generic
    Proprietary Name BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 140; 125; 125
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
    Labeler Name H2-Pharma, LLC
    Pharmaceutical Class Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050786
    Listing Certified Through 2024-12-31

    Package

    NDC 61269-0385-12 (61269038512)

    NDC Package Code 61269-385-12
    Billing NDC 61269038512
    Package 1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 2023-07-31
    NDC Exclude Flag N
    Pricing Information N/A