NDC 50458-647

Topamax

Topiramate

Topamax is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Topiramate.

Product ID50458-647_007c7ba9-3103-4238-9524-a9421607912d
NDC50458-647
Product TypeHuman Prescription Drug
Proprietary NameTopamax
Generic NameTopiramate
Dosage FormCapsule, Coated Pellets
Route of AdministrationORAL
Marketing Start Date1998-11-01
Marketing CategoryNDA / NDA
Application NumberNDA020844
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameTOPIRAMATE
Active Ingredient Strength15 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 Through2020-12-31

Packaging

NDC 50458-647-65

60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-647-65)
Marketing Start Date1998-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-647-65 [50458064765]

Topamax CAPSULE, COATED PELLETS
Marketing CategoryNDA
Application NumberNDA020844
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-11-01

Drug Details

Active Ingredients

IngredientStrength
TOPIRAMATE15 mg/1

OpenFDA Data

SPL SET ID:21628112-0c47-11df-95b3-498d55d89593
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199889
  • 199888
  • 152855
  • 845478
  • 845479
  • 199890
  • 205316
  • 151229
  • 151228
  • 151227
  • 151226
  • 205315
  • UPC Code
  • 0350458639650
  • 0350458640656
  • 0350458645651
  • 0350458641653
  • 0350458647655
  • 0350458642650
  • Pharmacological Class

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

    Medicade Reported Pricing

    50458064765 TOPAMAX 15 MG SPRINKLE CAP

    Pricing Unit: EA | Drug Type:

    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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