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  5. NDC Package Code: 83012-038-99 Cyltezo

NDC Package 83012-038-99 Cyltezo

Liquid - 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:
83012-038-99
Package Description:
50 mg in 1 BAG
Product Code:
83012-038
Non-Proprietary Name:
Cyltezo
Substance Name:
Adalimumab
Usage Information:
Adalimumab is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This medication is also used to treat certain skin disorders (such as plaque-type psoriasis, hidradenitis suppurativa). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis. Adalimumab belongs to a class of drugs known as TNF blockers. By reducing joint swelling, this medication helps to reduce further joint damage and preserve joint function. Adalimumab is also used to treat certain bowel conditions (Crohn's disease, ulcerative colitis) and a certain eye disease (uveitis).
11-Digit NDC Billing Format:
83012003899
Product Type:
Drug For Further Processing
Labeler Name:
Boehringer Ingelheim Fremont, Inc.
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s):
  • ADALIMUMAB 50 mg/50mg
    • 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:
    05-04-2023
    Listing Expiration Date:
    12-31-2025
    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 83012-038-99?

    The NDC Packaged Code 83012-038-99 is assigned to an UNFINISHED drug package of 50 mg in 1 bag of Cyltezo, drug for further processing labeled by Boehringer Ingelheim Fremont, Inc.. The product's dosage form is liquid and is administered via form.

    Is NDC 83012-038 included in the NDC Directory?

    Yes, Cyltezo is an UNFINISHED PRODUCT with code 83012-038 that is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Fremont, Inc. on May 04, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83012-038-99?

    The 11-digit format is 83012003899. 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
    5-3-283012-038-995-4-283012-0038-99