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  5. NDC Package Code: 43528-003-05 Heplisav-b

NDC Package 43528-003-05 Heplisav-b

Hepatitis B Vaccine (recombinant) Adjuvanted Injection, Solution Intramuscular - 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:
43528-003-05
Package Description:
5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (43528-003-01)
Product Code:
43528-003
Proprietary Name:
Heplisav-b
Non-Proprietary Name:
Hepatitis B Vaccine (recombinant) Adjuvanted
Substance Name:
Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen
Usage Information:
This vaccine is used to help prevent infection from the hepatitis B virus. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection can prevent these problems. Hepatitis B vaccine is a genetically engineered (man-made in the laboratory) piece of the virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis B virus. Hepatitis B vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS; hepatitis A, hepatitis C or hepatitis E; HPV virus which causes genital warts and other problems). The vaccine is recommended for people of all ages, especially those at an increased risk of getting the infection. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with persistent hepatitis B infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas.
11-Digit NDC Billing Format:
43528000305
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Injection
  • RxCUI: 1994347 - 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Injection
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 20 MCG per 0.5 ML Injection
  • RxCUI: 1994347 - hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection
    • Product Type:
    Vaccine
    Labeler Name:
    Dynavax Technologies Corporation
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL
    • Pharmacologic Class(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Hepatitis B Vaccines - [CS]
  • Inactivated Hepatitis B Virus Vaccine - [EPC] (Established Pharmacologic Class)
  • Vaccines, Inactivated - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125428
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-01-2018
    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 43528-003-05?

    The NDC Packaged Code 43528-003-05 is assigned to a package of 5 syringe in 1 carton / .5 ml in 1 syringe (43528-003-01) of Heplisav-b, a vaccine label labeled by Dynavax Technologies Corporation. The product's dosage form is injection, solution and is administered via intramuscular form.

    Is NDC 43528-003 included in the NDC Directory?

    Yes, Heplisav-b with product code 43528-003 is active and included in the NDC Directory. The product was first marketed by Dynavax Technologies Corporation on January 01, 2018 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 43528-003-05?

    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 43528-003-05?

    The 11-digit format is 43528000305. 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
    5-3-243528-003-055-4-243528-0003-05