Rotateq Solution
NDC Package 0006-4047-41

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

Package Information

Rotateq (rotavirus vaccine, live, oral, pentavalent) solution is rotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. This formulation utilizes a solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4047 and is authorized under FDA application BLA125122.

Identification & Billing

NDC Package Code
0006-4047-41
Package Description
10 POUCH in 1 CARTON / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01)
Product Code
0006-4047
11-Digit Billing Format
00006404741
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 798297 - rotavirus, live pentavalent (RV5) Oral Vaccine
  • RxCUI: 798297 - human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension
  • RxCUI: 798300 - RotaTeq, Rotavirus, live pentavalent (RV5) Oral Vaccine
  • RxCUI: 798300 - human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension [RotaTeq]

Clinical Specifications

Proprietary Name
Rotateq
Non-Proprietary Name
Rotavirus Vaccine, Live, Oral, Pentavalent
Substance Name
Human Rotavirus A Type G1p7(5) Strain Wi79 Live Antigen; Human Rotavirus A Type G2p7(5) Strain Sc2 Live Antigen; Human Rotavirus A Type G3p7(5) Strain Wi78 Live Antigen; Human Rotavirus A Type G4p7(5) Strain Brb Live Antigen; Human Rotavirus A Type G6p1a(8) Strain Wi79 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)
Pharmacologic Class
Usage Information
RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2)].

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA125122
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-03-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0006-4047). Click a package code to view its specific billing and regulatory data.

0006-4047-20
25 POUCH in 1 CARTON / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01)

* 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 0006-4047-41 identifies a specific commercial package of 10 pouch in 1 carton / 1 tube in 1 pouch (0006-4047-02) / 2 ml in 1 tube (0006-4047-01) of Rotateq, a vaccine label labeled by Merck Sharp & Dohme Llc. This solution is formulated for oral use and contains human rotavirus a type g1p7(5) strain wi79 live antigen; human rotavirus a type g2p7(5) strain sc2 live antigen; human rotavirus a type g3p7(5) strain wi78 live antigen; human rotavirus a type g4p7(5) strain brb live antigen; human rotavirus a type g6p1a(8) strain wi79 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 Merck Sharp & Dohme Llc on February 03, 2006. The current certification is valid through December 31, 2027.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006404741. 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 (4-4-2)
0006-4047-41
11-Digit CMS (5-4-2)
00006-4047-41

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