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  5. NDC Package Code: 63459-416-99 Tiagabine Hydrochloride

NDC Package 63459-416-99 Tiagabine Hydrochloride

Tablet, Film Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63459-416-99
Package Description:
31115 TABLET, FILM COATED in 1 DRUM
Product Code:
63459-416
Non-Proprietary Name:
Tiagabine Hydrochloride
Substance Name:
Tiagabine Hydrochloride
Usage Information:
GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
11-Digit NDC Billing Format:
63459041699
NDC to RxNorm Crosswalk:
  • RxCUI: 1299903 - tiaGABine HCl 12 MG Oral Tablet
  • RxCUI: 1299903 - tiagabine hydrochloride 12 MG Oral Tablet
  • RxCUI: 1299909 - tiaGABine HCl 16 MG Oral Tablet
  • RxCUI: 1299909 - tiagabine hydrochloride 16 MG Oral Tablet
  • RxCUI: 1299911 - tiaGABine HCl 2 MG Oral Tablet
    • Product Type:
    Drug For Further Processing
    Labeler Name:
    Cephalon, Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Active Ingredient(s):
  • TIAGABINE HYDROCHLORIDE 16 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    02-08-2010
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63459-416-99?

    The NDC Packaged Code 63459-416-99 is assigned to an UNFINISHED drug package of 31115 tablet, film coated in 1 drum of Tiagabine Hydrochloride, drug for further processing labeled by Cephalon, Llc. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 63459-416 included in the NDC Directory?

    Yes, Tiagabine Hydrochloride is an UNFINISHED PRODUCT with code 63459-416 that is active and included in the NDC Directory. The product was first marketed by Cephalon, Llc on February 08, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63459-416-99?

    The 11-digit format is 63459041699. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263459-416-995-4-263459-0416-99