NDC 69401-000 Vivotif

Salmonella Typhi Ty21a Capsule, Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69401-000
Proprietary Name:
Vivotif
Non-Proprietary Name: [1]
Salmonella Typhi Ty21a
Substance Name: [2]
Salmonella Typhi Ty21a Live Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Emergent Travel Health Inc.
    Labeler Code:
    69401
    FDA Application Number: [6]
    BLA103123
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    03-16-1992
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - SALMON/WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    16 MM
    Score:
    1

    Product Packages

    NDC Code 69401-000-02

    Package Description: 1 BLISTER PACK in 1 CARTON / 4 CAPSULE, COATED in 1 BLISTER PACK (69401-000-01)

    Product Details

    What is NDC 69401-000?

    The NDC code 69401-000 is assigned by the FDA to the product Vivotif which is a vaccine label product labeled by Emergent Travel Health Inc.. The generic name of Vivotif is salmonella typhi ty21a. The product's dosage form is capsule, coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 69401-000-02 1 blister pack in 1 carton / 4 capsule, coated in 1 blister pack (69401-000-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Vivotif?

    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.

    What are Vivotif Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Vivotif UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • SALMONELLA TYPHI TY21A LIVE ANTIGEN (UNII: 0MZI008M96)
    • SALMONELLA TYPHI TY21A LIVE ANTIGEN (UNII: 0MZI008M96) (Active Moiety)

    Which are Vivotif Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Vivotif?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Vivotif?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Typhoid Vaccine


    What is typhoid? Typhoid (typhoid fever) is a serious disease. It is caused by bacteria called Salmonella Typhi. Typhoid causes a high fever, fatigue, weakness, stomach pains, headache, loss of appetite, and sometimes a rash. If it is not treated, it can kill up to 30% of people who get it. Some people who get typhoid become ''carriers,'' who can spread the disease to others. Generally, people get typhoid from contaminated food or water. Typhoid is rare in the U.S., and most U.S. citizens who get the disease get it while traveling. Typhoid strikes about 21 million people a year around the world and kills about 200,000.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".