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    NDC 68382-0640-06 Dutasteride and tamsulosin hydrochloride .5; .4 mg/1; mg/1 Details

    Dutasteride and tamsulosin hydrochloride .5; .4 mg/1; mg/1

    Dutasteride and tamsulosin hydrochloride is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE.

    Product Information

    NDC 68382-0640
    Product ID 68382-640_82a42093-2426-48c6-aee7-1ac70e2dab57
    Associated GPIs 56859902250120
    GCN Sequence Number 066352
    GCN Sequence Number Description dutasteride/tamsulosin HCl CPMP 24HR 0.5-0.4 MG ORAL
    HIC3 Q9C
    HIC3 Description BPH 5-ALPHA-REDUCTASE INHIB-ALPHA1-ADRENOCEP ANTAG
    GCN 28596
    HICL Sequence Number 036984
    HICL Sequence Number Description DUTASTERIDE/TAMSULOSIN HCL
    Brand/Generic Generic
    Proprietary Name Dutasteride and tamsulosin hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dutasteride and tamsulosin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength .5; .4
    Active Ingredient Units mg/1; mg/1
    Substance Name DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207769
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0640-06 (68382064006)

    NDC Package Code 68382-640-06
    Billing NDC 68382064006
    Package 30 CAPSULE in 1 BOTTLE (68382-640-06)
    Marketing Start Date 2018-06-04
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 2.03367
    Pricing Unit EA
    Effective Date 2022-11-23
    NDC Description DUTASTERIDE-TAMSULOSIN 0.5-0.4
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2022-11-23
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL d6557691-7910-4006-9268-410583e437d1 Details

    Revised: 10/2022