0093-8072 NDC - TIAGABINE HYDROCHLORIDE

Drug Information

Product NDC: 0093-8072

Proprietary Name: Tiagabine Hydrochloride

Non Proprietary Name: Tiagabine Hydrochloride

Active Ingredient(s):
  • 12 mg/1 TIAGABINE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Anti-epileptic Agent [EPC];
  • Decreased Central Nervous System Disorganized Electrical Activity [PE]

Labeler Information

Labeler Name: Teva Pharmaceuticals USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020646
Marketing Category: NDA AUTHORIZED GENERIC
Start Marketing Date:3/9/2018

Package Information

No. Package Code Package Description Billing Unit
10093-8072-5630 TABLET, FILM COATED in 1 BOTTLE (0093-8072-56)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0093-8072The 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 NAMETiagabine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETiagabine HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe 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 DATE3/9/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDA AUTHORIZED GENERICProduct 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 NUMBERNDA020646This 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 NAMETeva Pharmaceuticals USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETIAGABINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH12 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 

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This page was last updated on: 8/16/2019