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  5. NDC Package Code: 58284-208-01 Brixadi

NDC Package 58284-208-01 Brixadi

Buprenorphine Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
58284-208-01
Package Description:
1 SYRINGE, GLASS in 1 CARTON / .16 mL in 1 SYRINGE, GLASS
Product Code:
58284-208
Proprietary Name:
Brixadi
Non-Proprietary Name:
Buprenorphine
Substance Name:
Buprenorphine
Usage Information:
This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Buprenorphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of opioid pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking opioids. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
11-Digit NDC Billing Format:
58284020801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2639021 - buprenorphine 8 MG in 0.16 ML Weekly Extended Release Prefilled Syringe
  • RxCUI: 2639021 - 0.16 ML buprenorphine 50 MG/ML Prefilled Syringe
  • RxCUI: 2639021 - buprenorphine 8 MG per 0.16 ML extended release Prefilled Syringe
  • RxCUI: 2639027 - Brixadi 8 MG in 0.16 ML Weekly Extended Release Prefilled Syringe
  • RxCUI: 2639027 - 0.16 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Braeburn Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • BUPRENORPHINE 8 mg/.16mL
    • Pharmacologic Class(es):
  • Partial Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA210136
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-06-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 58284-208-01?

    The NDC Packaged Code 58284-208-01 is assigned to a package of 1 syringe, glass in 1 carton / .16 ml in 1 syringe, glass of Brixadi, a human prescription drug labeled by Braeburn Inc.. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 58284-208 included in the NDC Directory?

    Yes, Brixadi with product code 58284-208 is active and included in the NDC Directory. The product was first marketed by Braeburn Inc. on June 06, 2023 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 NDC billing unit for package 58284-208-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 58284-208-01?

    The 11-digit format is 58284020801. 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
    5-3-258284-208-015-4-258284-0208-01