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    NDC 60665-0003-03 Sambrosa 9.78 mg/3mL Details

    Sambrosa 9.78 mg/3mL

    Sambrosa is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Sambrosa Care, Inc.. The primary component is DOXYLAMINE SUCCINATE.

    Product Information

    NDC 60665-0003
    Product ID 60665-003_cf863586-21cb-3bef-e053-2995a90abcbf
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Sambrosa
    Proprietary Name Suffix Night
    Non-Proprietary Name DOXYLAMINE SUCCINATE
    Product Type HUMAN OTC DRUG
    Dosage Form SYRUP
    Route ORAL
    Active Ingredient Strength 9.78
    Active Ingredient Units mg/3mL
    Substance Name DOXYLAMINE SUCCINATE
    Labeler Name Sambrosa Care, Inc.
    Pharmaceutical Class Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 60665-0003-03 (60665000303)

    NDC Package Code 60665-003-03
    Billing NDC 60665000303
    Package 1 BOTTLE in 1 CARTON (60665-003-03) / 300 mL in 1 BOTTLE
    Marketing Start Date 2020-01-10
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL acdc8740-6231-d1e8-e053-2995a90a3b8d Details

    Revised: 10/2021