Search by Drug Name or NDC

    NDC 71205-0914-60 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 Proficient Rx LP. The primary component is TEMAZEPAM.

    Product Information

    NDC 71205-0914
    Product ID 71205-914_40b473bd-d806-4631-a7ff-58ccc51fd201
    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 Proficient Rx LP
    Pharmaceutical Class Benzodiazepine [EPC], Benzodiazepines [CS]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA071456
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0914-60 (71205091460)

    NDC Package Code 71205-914-60
    Billing NDC 71205091460
    Package 60 CAPSULE in 1 BOTTLE (71205-914-60)
    Marketing Start Date 2021-07-14
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ccf04879-3ad5-4fc3-89f5-879c97887017 Details

    Revised: 4/2022