42549-620 NDC - TOPIRAMATE ()

Drug Information

  • Product NDC: 42549-620
  • Proprietary Name: TOPIRAMATE
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: STAT Rx USA LLC
Product Type:
FDA Application Number: ANDA090278
Marketing Category: ANDA
Start Marketing Date:3/27/2009

Package Information

No. Package Code Package Description Billing Unit
142549-620-12120 TABLET, FILM COATED in 1 BOTTLE (42549-620-12)
242549-620-3030 TABLET, FILM COATED in 1 BOTTLE (42549-620-30)
342549-620-6060 TABLET, FILM COATED in 1 BOTTLE (42549-620-60)EA
442549-620-9090 TABLET, FILM COATED in 1 BOTTLE (42549-620-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC42549-620The 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.
PROPRIETARY NAMETOPIRAMATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
START MARKETING DATE3/27/2009 
MARKETING CATEGORY NAMEANDA 
APPLICATION NUMBERANDA090278 
LABELER NAMESTAT Rx USA LLCName of Company corresponding to the labeler code segment of the Product NDC.

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

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