Rotarix Solution
NDC Package 58160-740-21

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

Package Information

Rotarix (rotavirus vaccine, live, oral) solution is 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)]. This formulation utilizes a solution delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-740 and is authorized under FDA application BLA125265.

Identification & Billing

NDC Package Code
58160-740-21
Package Description
10 APPLICATOR in 1 CARTON / 1.5 mL in 1 APPLICATOR (58160-740-02)
Product Code
58160-740
11-Digit Billing Format
58160074021
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Rotarix
Non-Proprietary Name
Rotavirus Vaccine, Live, Oral
Substance Name
Human Rotavirus A Type G1p(8) Strain Rix4414 Live Antigen
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN 1000 [CCID_50]/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125265
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-01-2023
Listing Expiration
12-31-2027
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 58160-740-21 identifies a specific commercial package of 10 applicator in 1 carton / 1.5 ml in 1 applicator (58160-740-02) of Rotarix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This solution is formulated for oral use and contains human rotavirus a type g1p(8) strain rix4414 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 Glaxosmithkline Biologicals Sa on February 01, 2023. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160074021. 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 (5-3-2)
58160-740-21
11-Digit CMS (5-4-2)
58160-0740-21

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