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  5. NDC Package Code: 0310-6540-04 Bydureon Bcise

NDC Package 0310-6540-04 Bydureon Bcise

Exenatide Injection, Suspension, Extended Release 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:
0310-6540-04
Package Description:
4 CARTRIDGE in 1 CARTON / .85 mL in 1 CARTRIDGE (0310-6540-01)
Product Code:
0310-6540
Proprietary Name:
Bydureon Bcise
Non-Proprietary Name:
Exenatide
Substance Name:
Exenatide
Usage Information:
Exenatide is used either alone or with other medications, and with a proper diet and exercise program, to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Exenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar (such as after a meal) and decreasing the amount of sugar your liver makes. Exenatide is not a substitute for insulin if you require insulin treatment.
11-Digit NDC Billing Format:
00310654004
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1990866 - exenatide 2 MG in 0.85 mL Auto-Injector
  • RxCUI: 1990866 - 0.85 ML exenatide 2.35 MG/ML Auto-Injector
  • RxCUI: 1990866 - exenatide 2 MG per 0.85 mL Auto-Injector
  • RxCUI: 1990869 - BYDUREON BCise 2 MG in 0.85 mL Auto-Injector
  • RxCUI: 1990869 - 0.85 ML exenatide 2.35 MG/ML Auto-Injector [Bydureon]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    Dosage Form:
    Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • EXENATIDE 2 mg/.85mL
    • Pharmacologic Class(es):
  • GLP-1 Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Glucagon-Like Peptide 1 - [CS]
  • Glucagon-like Peptide-1 (GLP-1) Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA209210
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-01-2017
    Listing Expiration Date:
    12-31-2025
    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 0310-6540-04?

    The NDC Packaged Code 0310-6540-04 is assigned to a package of 4 cartridge in 1 carton / .85 ml in 1 cartridge (0310-6540-01) of Bydureon Bcise, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is injection, suspension, extended release and is administered via subcutaneous form.

    Is NDC 0310-6540 included in the NDC Directory?

    Yes, Bydureon Bcise with product code 0310-6540 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on December 01, 2017 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 NDC billing unit for package 0310-6540-04?

    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 0310-6540-04?

    The 11-digit format is 00310654004. 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 4-4-2 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
    4-4-20310-6540-045-4-200310-6540-04