Vivotif-b
NDC 21695-526
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Vivotif-b is a BLA-approved product labeled by Rebel Distributors Corp. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a pink product. This product entry covers the primary NDC 21695-526 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
21695-526
Proprietary Name:
Vivotif-b
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
21695
Product Label ID:
FDA Application Number: [6]
BLA103123
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
12-15-1989
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Product Characteristics
Color(s):
PINK (C48328 - SALMON)
WHITE (C48325)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 21695-526?
The NDC code 21695-526 is assigned by the FDA to the product Vivotif-b. This pharmaceutical product is labeled by Rebel Distributors Corp and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 21695-526-04. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O)
- SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- SUCROSE (UNII: C151H8M554)
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- AMINO ACIDS (UNII: 0O72R8RF8A)
- LACTOSE (UNII: J2B2A4N98G)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
What is the NDC to RxNorm Crosswalk for this product?
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
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
