68382-863 NDC - TOPIRAMATE

Drug Information

Product NDC: 68382-863

Proprietary Name: Topiramate

Non Proprietary Name: Topiramate

Active Ingredient(s):
  • 25 mg/1 TOPIRAMATE

Administration Route(s): ORAL


Pharmacy Class(es):
  • Decreased Central Nervous System Disorganized Electrical Activity [PE];
  • Cytochrome P450 3A4 Inducers [MoA];
  • Cytochrome P450 2C19 Inhibitors [MoA]

Labeler Information

Labeler Name: Zydus Pharmaceuticals (USA) Inc.
FDA Application Number: ANDA207382
Marketing Category: ANDA
Start Marketing Date:4/5/2018

Package Information

No. Package Code Package Description Billing Unit
168382-863-01100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-01)
268382-863-05500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05)
368382-863-0630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06)
468382-863-1690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16)
568382-863-7710 BLISTER PACK in 1 CARTON (68382-863-77) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC68382-863The 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 DATE4/5/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA207382This 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 NAMEZydus Pharmaceuticals (USA) Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETOPIRAMATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 

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This page was last updated on: 9/11/2020