31722-547 NDC - TOPIRAMATE (TOPIRAMATE)

Drug Information

  • Product NDC: 31722-547
  • Proprietary Name: TOPIRAMATE
  • Non Proprietary Name: Topiramate
  • Active Ingredient(s): 25 mg/1 TOPIRAMATE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE, EXTENDED RELEASE
  • 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: Camber Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA217443
Marketing Category: ANDA
Start Marketing Date:4/1/2026

Package Information

No. Package Code Package Description Billing Unit
131722-547-3030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-547-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC31722-547The 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 NAMETOPIRAMATEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETopiramateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/1/2026This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAIndicates 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.
APPLICATION NUMBERANDA217443The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
LABELER NAMECamber Pharmaceuticals, Inc.The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
SUBSTANCE NAMETOPIRAMATEThe translation of the dosage form Code submitted by the firm.
ACTIVE NUMERATOR STRENGTH25 
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: 5/7/2026

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