NDC 70518-1393

Topamax

Topiramate

Topamax is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Topiramate.

Product ID70518-1393_752aaba0-2a76-cabb-e053-2991aa0a6fd7
NDC70518-1393
Product TypeHuman Prescription Drug
Proprietary NameTopamax
Generic NameTopiramate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-08-29
Marketing CategoryNDA / NDA
Application NumberNDA020505
Labeler NameREMEDYREPACK INC.
Substance NameTOPIRAMATE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1393-0

30 TABLET, COATED in 1 BLISTER PACK (70518-1393-0)
Marketing Start Date2018-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1393-0 [70518139300]

Topamax TABLET, COATED
Marketing CategoryNDA
Application NumberNDA020505
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-29
Marketing End Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE100 mg/1

OpenFDA Data

SPL SET ID:db9876a2-c348-4ae1-8c48-73a582dab38d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199889
  • 151228

    • 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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