Gabitril
NDC 63459-404
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Gabitril is a NDA-approved product labeled by Cephalon, Llc. Tiagabine is used with other medications to treat certain types of seizures (focal seizures). It is supplied as a product. This product entry covers the primary NDC 63459-404 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63459-404
Proprietary Name:
Gabitril
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63459
FDA Application Number: [6]
NDA020646
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
04-01-2001
End Marketing Date: [10]
04-30-2024
Listing Expiration Date: [11]
04-30-2024
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 63459-404?
The NDC code 63459-404 is assigned by the FDA to the product Gabitril. This pharmaceutical product is labeled by Cephalon, Llc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 63459-404-01, 63459-404-30, 63459-404-99. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Tiagabine is used with other medications to treat certain types of seizures (focal seizures). It works by reducing the spread of seizure activity in the brain. This medication is known as an anticonvulsant or anti-epileptic drug. When tiagabine has been used for conditions other than epilepsy, serious reactions (including seizures in people who have never had them) have occurred. Talk to your doctor for more details.
What are Active Ingredients of this product?
An 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.
- TIAGABINE HYDROCHLORIDE 4 mg/1 - A nipecotic acid derivative that acts as a GABA uptake inhibitor and anticonvulsant agent. It is used in the treatment of EPILEPSY, for refractory PARTIAL SEIZURES.
* Please review the full disclaimer at the bottom of this page.
Patient Education
Tiagabine
Tiagabine is used in combination with other medications to treat partial seizures (a type of epilepsy). Tiagabine is in a class of medications called anticonvulsants. It is not known exactly how tiagabine works, but it increases the amount of natural chemicals in the brain that prevent seizure activity.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This 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.
What is the Marketing Category? Product 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
