Search by Drug Name or NDC

    NDC 71205-0195-90 topiramate 100 mg/1 Details

    topiramate 100 mg/1

    topiramate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is TOPIRAMATE.

    Product Information

    NDC 71205-0195
    Product ID 71205-195_3741e5f0-0c1b-479f-b3a7-3f240cddb98d
    Associated GPIs 72600075000330
    GCN Sequence Number 026170
    GCN Sequence Number Description topiramate TABLET 100 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 36551
    HICL Sequence Number 011060
    HICL Sequence Number Description TOPIRAMATE
    Brand/Generic Generic
    Proprietary Name topiramate
    Proprietary Name Suffix n/a
    Non-Proprietary Name topiramate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name TOPIRAMATE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090162
    Listing Certified Through 2024-12-31

    Package

    NDC 71205-0195-90 (71205019590)

    NDC Package Code 71205-195-90
    Billing NDC 71205019590
    Package 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-195-90)
    Marketing Start Date 2019-01-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 584e16c5-5ffb-4bfc-ba80-4340afd25e8e Details

    Revised: 1/2020