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    NDC 50458-0388-30 RAZADYNE 16 mg/1 Details

    RAZADYNE 16 mg/1

    RAZADYNE is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is GALANTAMINE HYDROBROMIDE.

    Product Information

    NDC 50458-0388
    Product ID 50458-388_7eab135b-9825-43c2-b70a-13c1eef3557d
    Associated GPIs 62051030107030
    GCN Sequence Number 058239
    GCN Sequence Number Description galantamine HBr CAP24H PEL 16 MG ORAL
    HIC3 J1B
    HIC3 Description CHOLINESTERASE INHIBITORS
    GCN 23606
    HICL Sequence Number 016520
    HICL Sequence Number Description GALANTAMINE HBR
    Brand/Generic Brand
    Proprietary Name RAZADYNE
    Proprietary Name Suffix n/a
    Non-Proprietary Name galantamine hydrobromide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 16
    Active Ingredient Units mg/1
    Substance Name GALANTAMINE HYDROBROMIDE
    Labeler Name Janssen Pharmaceuticals, Inc.
    Pharmaceutical Class Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021615
    Listing Certified Through n/a

    Package

    NDC 50458-0388-30 (50458038830)

    NDC Package Code 50458-388-30
    Billing NDC 50458038830
    Package 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50458-388-30)
    Marketing Start Date 2004-12-24
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc Details

    Revised: 10/2022