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    NDC 71205-0286-30 ZOLPIDEM TARTRATE 12.5 mg/1 Details

    ZOLPIDEM TARTRATE 12.5 mg/1

    ZOLPIDEM TARTRATE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is ZOLPIDEM TARTRATE.

    Product Information

    NDC 71205-0286
    Product ID 71205-286_bde02c60-5382-4505-b806-ddb2f5f9deab
    Associated GPIs 60204080100420
    GCN Sequence Number 059697
    GCN Sequence Number Description zolpidem tartrate TAB MPHASE 12.5 MG ORAL
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 25457
    HICL Sequence Number 007842
    HICL Sequence Number Description ZOLPIDEM TARTRATE
    Brand/Generic Generic
    Proprietary Name ZOLPIDEM TARTRATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name Zolpidem Tartrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/1
    Substance Name ZOLPIDEM TARTRATE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA078970
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0286-30 (71205028630)

    NDC Package Code 71205-286-30
    Billing NDC 71205028630
    Package 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-286-30)
    Marketing Start Date 2019-06-21
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL acf9f431-3013-4cfd-ba4d-c4013f20bdab Details

    Revised: 11/2022