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  5. NDC Package Code: 68621-0046-1 Vigabatrin

NDC Package 68621-0046-1 Vigabatrin

Powder, For Solution - 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:
68621-0046-1
Package Description:
1 BAG in 1 BOX / 1000 PACKET in 1 BAG / 10 mL in 1 PACKET
Product Code:
68621-0046
Non-Proprietary Name:
Vigabatrin
Substance Name:
Vigabatrin
Usage Information:
Vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. Vigabatrin has also been used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment. Vigabatrin is an anticonvulsant. It is thought to work by stopping the breakdown of a natural calming substance (GABA) in the brain.
11-Digit NDC Billing Format:
68621004601
Product Type:
Drug For Further Processing
Labeler Name:
Catalent Germany Schorndorf Gmbh
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Active Ingredient(s):
  • VIGABATRIN 50 mg/mL
    • 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:
    06-21-2018
    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 68621-0046-1?

    The NDC Packaged Code 68621-0046-1 is assigned to an UNFINISHED drug package of 1 bag in 1 box / 1000 packet in 1 bag / 10 ml in 1 packet of Vigabatrin, drug for further processing labeled by Catalent Germany Schorndorf Gmbh. The product's dosage form is powder, for solution and is administered via form.

    Is NDC 68621-0046 included in the NDC Directory?

    Yes, Vigabatrin is an UNFINISHED PRODUCT with code 68621-0046 that is active and included in the NDC Directory. The product was first marketed by Catalent Germany Schorndorf Gmbh on June 21, 2018 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 68621-0046-1?

    The 11-digit format is 68621004601. 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 5-4-1 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
    5-4-168621-0046-15-4-268621-0046-01