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    NDC 68382-0543-77 lansoprazole 15 mg/1 Details

    lansoprazole 15 mg/1

    lansoprazole is a ORAL CAPSULE, DELAYED RELEASE PELLETS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is LANSOPRAZOLE.

    Product Information

    NDC 68382-0543
    Product ID 68382-543_b828e447-56b6-4cab-bd49-053bcd4be948
    Associated GPIs 49270040006510
    GCN Sequence Number 030106
    GCN Sequence Number Description lansoprazole CAPSULE DR 15 MG ORAL
    HIC3 D4J
    HIC3 Description PROTON-PUMP INHIBITORS
    GCN 01697
    HICL Sequence Number 008993
    HICL Sequence Number Description LANSOPRAZOLE
    Brand/Generic Generic
    Proprietary Name lansoprazole
    Proprietary Name Suffix n/a
    Non-Proprietary Name lansoprazole
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, DELAYED RELEASE PELLETS
    Route ORAL
    Active Ingredient Strength 15
    Active Ingredient Units mg/1
    Substance Name LANSOPRAZOLE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202366
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0543-77 (68382054377)

    NDC Package Code 68382-543-77
    Billing NDC 68382054377
    Package 10 BLISTER PACK in 1 CARTON (68382-543-77) / 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (68382-543-30)
    Marketing Start Date 2013-08-23
    NDC Exclude Flag N
    Pricing Information N/A