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  5. NDC Package Code: 67651-0349-0 Berotralstat Hydrochloride

NDC Package 67651-0349-0 Berotralstat Hydrochloride

Capsule - 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:
67651-0349-0
Package Description:
34000 CAPSULE in 1 DRUM
Product Code:
67651-0349
Non-Proprietary Name:
Berotralstat Hydrochloride
Substance Name:
Berotralstat Hydrochloride
11-Digit NDC Billing Format:
67651034900
Product Type:
Drug For Further Processing
Labeler Name:
Patheon Pharmaceuticals Inc.
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
  • BEROTRALSTAT HYDROCHLORIDE 110 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:
    12-04-2020
    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 67651-0349-0?

    The NDC Packaged Code 67651-0349-0 is assigned to an UNFINISHED drug package of 34000 capsule in 1 drum of Berotralstat Hydrochloride, drug for further processing labeled by Patheon Pharmaceuticals Inc.. The product's dosage form is capsule and is administered via form.

    Is NDC 67651-0349 included in the NDC Directory?

    Yes, Berotralstat Hydrochloride is an UNFINISHED PRODUCT with code 67651-0349 that is active and included in the NDC Directory. The product was first marketed by Patheon Pharmaceuticals Inc. on December 04, 2020 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 67651-0349-0?

    The 11-digit format is 67651034900. 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
    5-4-167651-0349-05-4-267651-0349-00