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    NDC 71858-0017-04 Tirosint 62.5 ug/1 Details

    Tirosint 62.5 ug/1

    Tirosint is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by IBSA Pharma Inc.. The primary component is LEVOTHYROXINE SODIUM.

    Product Information

    NDC 71858-0017
    Product ID 71858-0017_0b274758-a84c-4e19-e063-6294a90a3b89
    Associated GPIs
    GCN Sequence Number 084590
    GCN Sequence Number Description levothyroxine sodium CAPSULE 62.5 MCG ORAL
    HIC3 P3A
    HIC3 Description THYROID HORMONES
    GCN 53931
    HICL Sequence Number 002849
    HICL Sequence Number Description LEVOTHYROXINE SODIUM
    Brand/Generic Brand
    Proprietary Name Tirosint
    Proprietary Name Suffix n/a
    Non-Proprietary Name levothyroxine sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 62.5
    Active Ingredient Units ug/1
    Substance Name LEVOTHYROXINE SODIUM
    Labeler Name IBSA Pharma Inc.
    Pharmaceutical Class Thyroxine [CS], l-Thyroxine [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021924
    Listing Certified Through 2024-12-31

    Package

    NDC 71858-0017-04 (71858001704)

    NDC Package Code 71858-0017-4
    Billing NDC 71858001704
    Package 3 BLISTER PACK in 1 CARTON (71858-0017-4) / 10 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 2023-03-01
    NDC Exclude Flag N
    Pricing Information N/A