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NDC 58160-854 Rotarix

Rotavirus Vaccine,Live,Oral Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58160-854?
  4. Rotarix Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
58160-854
Proprietary Name:
Rotarix
Non-Proprietary Name: [1]
Rotavirus Vaccine, Live, Oral
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Glaxosmithkline Biologicals Sa
Labeler Code:
58160
Product Label ID:
f3182470-1965-4e20-dbaf-e3506f893ea5
FDA Application Number: [6]
BLA125265
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
01-13-2011
End Marketing Date: [10]
02-24-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 58160-854?

The NDC code 58160-854 is assigned by the FDA to the product Rotarix which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Rotarix is rotavirus vaccine, live, oral. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 58160-854-52 1 kit in 1 carton * 10 vial in 1 carton (58160-851-10) / 1 ml in 1 vial (58160-851-01) * 1 ml in 1 applicator (58160-853-02). 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 Rotarix?

ROTARIX® is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.

Which are Rotarix UNII Codes?

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

  • HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN (UNII: KZ3L01D2PC)
  • HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN (UNII: KZ3L01D2PC) (Active Moiety)

Which are Rotarix 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 Rotarix?

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: 805576 - rotavirus, live attenuated (RV1) G1P[8] Oral Vaccine 1 mL Lyophilized Powder for Oral Suspension
  • RxCUI: 805576 - rotavirus vaccine, live attenuated, G1P[8] human 89-12 strain 1000000 UNT/ML Oral Suspension
  • RxCUI: 805576 - rotavirus, live attenuated (RV1) G1P[8] Oral Vaccine 1 ML Lyophilized Powder for Oral Suspension
  • RxCUI: 805579 - Rotarix, Rotavirus, live attenuated (RV1) G1P[8] Vaccine 1 mL Lyophilized Powder for Oral Suspension
  • RxCUI: 805579 - rotavirus vaccine, live attenuated, G1P[8] human 89-12 strain 1000000 UNT/ML Oral Suspension [Rotarix]

* Please review the disclaimer below.

Patient Education

Rotavirus Vaccine


Why get vaccinated? Rotavirus vaccine can prevent rotavirus disease. Rotavirus commonly causes severe, watery diarrhea, mostly in babies and young children. Vomiting and fever are also common in babies with rotavirus. Children may become dehydrated and need to be hospitalized and can even die.
[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.

[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.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".