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  5. NDC Package Code: 58160-740-21 Rotarix

NDC Package 58160-740-21 Rotarix

Rotavirus Vaccine,Live,Oral Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Rotarix
Non-Proprietary Name:
Rotavirus Vaccine, Live, Oral
Substance Name:
Human Rotavirus A Type G1p(8) Strain Rix4414 Live Antigen
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.
11-Digit NDC Billing Format:
58160074021
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • 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]
    • Product Type:
    Vaccine
    Labeler Name:
    Glaxosmithkline Biologicals Sa
    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(s):
  • 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(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Live Attenuated Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Rotavirus Vaccines - [CS]
  • Vaccines, Attenuated - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125265
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-01-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 58160-740-21?

    The NDC Packaged Code 58160-740-21 is assigned to a 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. The product's dosage form is solution and is administered via oral form.

    Is NDC 58160-740 included in the NDC Directory?

    Yes, Rotarix with product code 58160-740 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on February 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58160-740-21?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 58160-740-21?

    The 11-digit format is 58160074021. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-258160-740-215-4-258160-0740-21