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    NDC 28595-0550-49 NITROLINGUAL 400 ug/1 Details

    NITROLINGUAL 400 ug/1

    NITROLINGUAL is a ORAL SPRAY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allegis Pharmaceuticals, LLC. The primary component is NITROGLYCERIN.

    Product Information

    NDC 28595-0550
    Product ID 28595-550_0e77f59d-7759-18be-e063-6394a90afa66
    Associated GPIs 32100030002060
    GCN Sequence Number 044359
    GCN Sequence Number Description nitroglycerin SPRAY 400MCG/SPR TRANSLING
    HIC3 A7B
    HIC3 Description VASODILATORS,CORONARY
    GCN 92257
    HICL Sequence Number 000159
    HICL Sequence Number Description NITROGLYCERIN
    Brand/Generic Brand
    Proprietary Name NITROLINGUAL
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nitroglycerin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SPRAY
    Route ORAL
    Active Ingredient Strength 400
    Active Ingredient Units ug/1
    Substance Name NITROGLYCERIN
    Labeler Name Allegis Pharmaceuticals, LLC
    Pharmaceutical Class Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA018705
    Listing Certified Through 2025-12-31

    Package

    NDC 28595-0550-49 (28595055049)

    NDC Package Code 28595-550-49
    Billing NDC 28595055049
    Package 1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY
    Marketing Start Date 2019-07-01
    NDC Exclude Flag N
    Pricing Information N/A