Vivotif Capsule, Coated
NDC Package 50632-016-02

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

Package Information

Vivotif (salmonella typhi ty21a) capsules is vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. This formulation utilizes a capsule, coated delivery system. Marketed by Bavarian Nordic A/s, this product is identified by NDC 50632-016 and is authorized under FDA application BLA103123.

Identification & Billing

NDC Package Code
50632-016-02
Package Description
1 BLISTER PACK in 1 CARTON / 4 CAPSULE, COATED in 1 BLISTER PACK (50632-016-04)
Product Code
50632-016
11-Digit Billing Format
50632001602
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 762598 - typhoid vaccine live Ty21a 2,000,000,000 UNT Delayed Release Oral Capsule
  • RxCUI: 762598 - Salmonella typhi Ty21a live antigen 2000000000 UNT Delayed Release Oral Capsule
  • RxCUI: 762602 - Vivotif 2,000,000,000 UNT Delayed Release Oral Capsule
  • RxCUI: 762602 - Salmonella typhi Ty21a live antigen 2000000000 UNT Delayed Release Oral Capsule [Vivotif]
  • RxCUI: 762602 - Vivotif Berna 2,000,000,000 UNT Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Vivotif
Non-Proprietary Name
Salmonella Typhi Ty21a
Substance Name
Salmonella Typhi Ty21a Live Antigen
Dosage Form
Capsule, Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SALMONELLA TYPHI TY21A LIVE ANTIGEN 6000000000 [CFU]/1
Pharmacologic Class
Usage Information
Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.

Regulatory & Marketing

Labeler Name
Bavarian Nordic A/s
Product Type
Vaccine
FDA Application #
BLA103123
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2024
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 50632-016-02 identifies a specific commercial package of 1 blister pack in 1 carton / 4 capsule, coated in 1 blister pack (50632-016-04) of Vivotif, a vaccine label labeled by Bavarian Nordic A/s. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule, coated is formulated for oral use and contains salmonella typhi ty21a live 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 Bavarian Nordic A/s on July 01, 2024. The current certification is valid through December 31, 2026.

How is this Bavarian Nordic A/s product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50632001602. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
50632-016-02
11-Digit CMS (5-4-2)
50632-0016-02

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