Recombivax Hb Injection, Suspension
NDC Package 83703-085-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Recombivax Hb (hepatitis b vaccine (recombinant)) injection is this vaccine is used to help prevent infection from the hepatitis B virus. This formulation utilizes a injection, suspension delivery system. Marketed by Bamboo Us Bidco Llc, this product is identified by NDC 83703-085 and is authorized under FDA application BLA101066.

Identification & Billing

NDC Package Code
83703-085-02
Package Description
.5 mL in 1 SYRINGE
Product Code
83703-085
11-Digit Billing Format
83703008502
RxNorm Crosswalk
  • RxCUI: 830243 - hepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 ML Prefilled Syringe
  • RxCUI: 830243 - 1 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe
  • RxCUI: 830243 - hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe
  • RxCUI: 830243 - hepatitis B surface antigen vaccine 10 MCG per 1 ML Prefilled Syringe
  • RxCUI: 830245 - RECOMBIVAX HB adult vaccine 1 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Recombivax Hb
Non-Proprietary Name
Hepatitis B Vaccine (recombinant)
Substance Name
Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug/.5mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Bamboo Us Bidco Llc
Product Type
Vaccine
FDA Application #
BLA101066
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-26-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83703-085-02 identifies a specific commercial package of .5 ml in 1 syringe of Recombivax Hb, a vaccine label labeled by Bamboo Us Bidco Llc. This injection, suspension is formulated for intramuscular; subcutaneous use and contains hepatitis b virus subtype adw hbsag surface protein antigen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bamboo Us Bidco Llc on February 26, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Bamboo Us Bidco Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83703008502. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83703-085-02
11-Digit CMS (5-4-2)
83703-0085-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.