Twinrix Injection, Suspension
NDC Package 50090-1645-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Twinrix (hepatitis a and hepatitis b (recombinant) vaccine) injection is this combination vaccine is used to help prevent infection from the hepatitis A and B viruses. This formulation utilizes a injection, suspension delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-1645 and is authorized under FDA application BLA103850.

Identification & Billing

NDC Package Code
50090-1645-0
Package Description
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (50090-1645-9)
Product Code
11-Digit Billing Format
50090164500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 803369 - hepatitis A & hepatitis B (recombinant) vaccine (HepA-HepB) 1 ML Prefilled Syringe
  • RxCUI: 803369 - 1 ML hepatitis A vaccine (inactivated) strain HM175 720 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe
  • RxCUI: 803369 - hepatitis A vaccine (inactivated) strain HM175 720 UNT / hepatitis B surface antigen vaccine 0.02 MG per 1 ML Prefilled Syringe
  • RxCUI: 803369 - hepatitis A vaccine (inactivated) strain HM175 720 UNT / hepatitis B surface antigen vaccine 20 MCG per 1 ML Prefilled Syringe
  • RxCUI: 803371 - TWINRIX vaccine 1 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Twinrix
Non-Proprietary Name
Hepatitis A And Hepatitis B (recombinant) Vaccine
Substance Name
Hepatitis A Virus Strain Hm175 Antigen (formaldehyde Inactivated); Hepatitis B Virus Subtype Adw2 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.
Usage Information
This combination vaccine is used to help prevent infection from the hepatitis A and B viruses. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection with these viruses can prevent these problems. Hepatitis A/hepatitis B combination vaccine is made from whole, killed hepatitis A virus and a genetically engineered (man-made in the laboratory) piece of hepatitis B virus. It does not contain live virus, so you can not 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 A and hepatitis B. This combination vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS, hepatitis C/ hepatitis E, HPV virus which causes genital warts and other problems). The vaccine is recommended for people at an increased risk of getting these infections. 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 or active hepatitis A 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
A-s Medication Solutions
Product Type
Vaccine
FDA Application #
BLA103850
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-07-2007
Listing Expiration
12-31-2026
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 50090-1645-0 identifies a specific commercial package of 10 syringe in 1 carton / 1 ml in 1 syringe (50090-1645-9) of Twinrix, a vaccine label labeled by A-s Medication Solutions. This injection, suspension is formulated for intramuscular use and contains hepatitis a virus strain hm175 antigen (formaldehyde inactivated); hepatitis b virus subtype adw2 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 A-s Medication Solutions on June 07, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination vaccine is used to help prevent infection from the hepatitis A and B viruses. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection with these viruses can prevent these problems. Hepatitis A/hepatitis B combination vaccine is made from whole, killed hepatitis A virus and a genetically engineered (man-made in the laboratory) piece of hepatitis B virus. It does not contain live virus, so you can not 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 A and hepatitis B. This combination vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS, hepatitis C/ hepatitis E, HPV virus which causes genital warts and other problems). The vaccine is recommended for people at an increased risk of getting these infections. 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 or active hepatitis A 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 A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090164500. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
50090-1645-0
11-Digit CMS (5-4-2)
50090-1645-00

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