50458-642 NDC - TOPAMAX (TOPIRAMATE)

Drug Information

  • Product NDC: 50458-642
  • Proprietary Name: Topamax
  • Non Proprietary Name: topiramate
  • Active Ingredient(s): 200 mg/1 TOPIRAMATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, COATED
  • Pharmacy Class(es): Cytochrome P450 2C19 Inhibitors [MoA]; Cytochrome P450 3A4 Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020505
Marketing Category: NDA
Start Marketing Date:1/1/1997

Package Information

No. Package Code Package Description Billing Unit
150458-642-6560 TABLET, COATED in 1 BOTTLE (50458-642-65)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC50458-642The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMETopamaxProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NON PROPRIETARY NAMEtopiramateThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
DOSAGE FORM NAMETABLET, COATEDName of Company corresponding to the labeler code segment of the Product NDC.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/1997This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020505This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEJanssen Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETOPIRAMATEThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
ACTIVE NUMERATOR STRENGTH200 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] 

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This page was last updated on: 12/6/2025

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