NDC 61919-189

TOPAMAX

Topiramate

TOPAMAX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Topiramate.

Product ID61919-189_33c0fc7a-aa49-34ae-e054-00144ff8d46c
NDC61919-189
Product TypeHuman Prescription Drug
Proprietary NameTOPAMAX
Generic NameTopiramate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-05-10
Marketing CategoryANDA / ANDA
Application NumberANDA090162
Labeler NameDIRECT RX
Substance NameTOPIRAMATE
Active Ingredient Strength50 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-189-60

60 TABLET in 1 BOTTLE (61919-189-60)
Marketing Start Date2016-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-189-60 [61919018960]

TOPAMAX TABLET
Marketing CategoryANDA
Application NumberANDA090162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-10

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE50 mg/1

OpenFDA Data

SPL SET ID:33c0fc7a-aa48-34ae-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 151227
  • 151226

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    NDC Crossover Matching brand name "TOPAMAX" or generic name "Topiramate"

    NDCBrand NameGeneric Name
    70518-1393TopamaxTopamax
    21695-128TopamaxTopamax
    21695-130TopamaxTopamax
    21695-129TopamaxTopamax
    50458-647TopamaxTopamax
    50458-645TopamaxTopamax
    50458-642TopamaxTopamax
    50458-641TopamaxTopamax
    50458-639TopamaxTopamax
    50458-640TopamaxTopamax
    55289-433TopamaxTopamax
    61919-189TOPAMAXTOPAMAX
    70518-2165TopamaxTopamax
    70518-2753TopamaxTopamax
    80425-0092TopamaxTopamax
    0245-1071QUDEXYTopiramate
    0245-1072QUDEXYTopiramate
    0245-1073QUDEXYTopiramate
    0245-1074QUDEXYTopiramate
    0245-1075QUDEXYTopiramate
    0093-7335TopiramateTopiramate
    0093-7336TopiramateTopiramate
    0615-7562TopiramateTopiramate
    0615-7563TopiramateTopiramate
    0615-7564TopiramateTopiramate
    0615-7565TopiramateTopiramate
    0615-8138TopiramateTopiramate
    0615-8139TopiramateTopiramate

    Trademark Results [TOPAMAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOPAMAX
    TOPAMAX
    85391764 4128458 Live/Registered
    JOHNSON & JOHNSON
    2011-08-08
    TOPAMAX
    TOPAMAX
    78278329 2968496 Dead/Cancelled
    Johnson & Johnson
    2003-07-24
    TOPAMAX
    TOPAMAX
    74384910 1909122 Live/Registered
    JOHNSON & JOHNSON
    1993-04-23
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