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    NDC 67544-0136-20 Temazepam 15 mg/1 Details

    Temazepam 15 mg/1

    Temazepam is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is TEMAZEPAM.

    Product Information

    NDC 67544-0136
    Product ID 67544-136_6d75ac66-4a65-487b-a938-7414907c2632
    Associated GPIs 60201030000105
    GCN Sequence Number 003689
    GCN Sequence Number Description temazepam CAPSULE 15 MG ORAL
    HIC3 H21
    HIC3 Description SEDATIVE-HYPNOTICS - BENZODIAZEPINES
    GCN 13840
    HICL Sequence Number 001592
    HICL Sequence Number Description TEMAZEPAM
    Brand/Generic Generic
    Proprietary Name Temazepam
    Proprietary Name Suffix n/a
    Non-Proprietary Name temazepam
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 15
    Active Ingredient Units mg/1
    Substance Name TEMAZEPAM
    Labeler Name Aphena Pharma Solutions - Tennessee, LLC
    Pharmaceutical Class Benzodiazepine [EPC], Benzodiazepines [CS]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA071638
    Listing Certified Through 2024-12-31

    Package

    NDC 67544-0136-20 (67544013620)

    NDC Package Code 67544-136-20
    Billing NDC 67544013620
    Package 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20)
    Marketing Start Date 2004-09-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2461dfbd-5704-42f4-bde7-d1461811d898 Details

    Revised: 5/2019