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    NDC 76420-0500-09 Sumatriptan 100 mg/1 Details

    Sumatriptan 100 mg/1

    Sumatriptan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is SUMATRIPTAN SUCCINATE.

    Product Information

    NDC 76420-0500
    Product ID 76420-500_eacf382a-98ac-e3ad-e053-2995a90a44e8
    Associated GPIs
    GCN Sequence Number 017129
    GCN Sequence Number Description sumatriptan succinate TABLET 100 MG ORAL
    HIC3 H3F
    HIC3 Description ANTIMIGRAINE PREPARATIONS
    GCN 05701
    HICL Sequence Number 006587
    HICL Sequence Number Description SUMATRIPTAN SUCCINATE
    Brand/Generic Generic
    Proprietary Name Sumatriptan
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sumatriptan Succinate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name SUMATRIPTAN SUCCINATE
    Labeler Name Asclemed USA, Inc.
    Pharmaceutical Class Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078327
    Listing Certified Through 2024-12-31

    Package

    NDC 76420-0500-09 (76420050009)

    NDC Package Code 76420-500-09
    Billing NDC 76420050009
    Package 9 TABLET in 1 BLISTER PACK (76420-500-09)
    Marketing Start Date 2022-10-12
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 77f9f135-e840-48f0-81e8-73e08433e768 Details

    Revised: 10/2022