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    NDC 69238-1422-06 Naproxen Sodium and Diphenhydramine HCl 25; 220 mg/1; mg/1 Details

    Naproxen Sodium and Diphenhydramine HCl 25; 220 mg/1; mg/1

    Naproxen Sodium and Diphenhydramine HCl is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM.

    Product Information

    NDC 69238-1422
    Product ID 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
    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 Naproxen Sodium and Diphenhydramine HCl
    Proprietary Name Suffix n/a
    Non-Proprietary Name Naproxen Sodium and Diphenhydramine
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 25; 220
    Active Ingredient Units mg/1; mg/1
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
    Labeler Name Amneal Pharmaceuticals NY LLC
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209726
    Listing Certified Through 2024-12-31

    Package

    NDC 69238-1422-06 (69238142206)

    NDC Package Code 69238-1422-6
    Billing NDC 69238142206
    Package 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE
    Marketing Start Date 2018-10-23
    NDC Exclude Flag N
    Pricing Information N/A