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    NDC 16110-0518-15 Altabax 10 mg/g Details

    Altabax 10 mg/g

    Altabax is a TOPICAL OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almirall, LLC. The primary component is RETAPAMULIN.

    Product Information

    NDC 16110-0518
    Product ID 16110-518_428b4572-8671-4085-92b7-17d14d20f225
    Associated GPIs 90100095004220
    GCN Sequence Number 062599
    GCN Sequence Number Description retapamulin OINT. (G) 1 % TOPICAL
    HIC3 T0B
    HIC3 Description TOPICAL ANTIBIOTIC PLEUROMUTILIN DERIVATIVES
    GCN 98373
    HICL Sequence Number 034708
    HICL Sequence Number Description RETAPAMULIN
    Brand/Generic Brand
    Proprietary Name Altabax
    Proprietary Name Suffix n/a
    Non-Proprietary Name retapamulin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OINTMENT
    Route TOPICAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/g
    Substance Name RETAPAMULIN
    Labeler Name Almirall, LLC
    Pharmaceutical Class Diterpenes [CS], Pleuromutilin Antibacterial [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022055
    Listing Certified Through 2024-12-31

    Package

    NDC 16110-0518-15 (16110051815)

    NDC Package Code 16110-518-15
    Billing NDC 16110051815
    Package 1 TUBE in 1 CARTON (16110-518-15) / 15 g in 1 TUBE
    Marketing Start Date 2016-05-01
    NDC Exclude Flag N
    Pricing Information N/A