NDC 0006-4047-41 Rotateq

Rotavirus Vaccine, Live, Oral, Pentavalent

NDC Package Code 0006-4047-41

The NDC Code 0006-4047-41 is assigned to a 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 lable labeled by Merck Sharp & Dohme Corp.. The product's dosage form is solution and is administered via oral form.

Field Name Field Value
NDC 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)
Proprietary Name Rotateq What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Rotavirus Vaccine, Live, Oral, Pentavalent 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.
11-Digit NDC Billing Format 00006404741 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Vaccine 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.
Labeler Name Merck Sharp & Dohme Corp.
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 G1P7(5) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL
  • HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN 2800000 [iU]/2mL
  • HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN 2200000 [iU]/2mL
  • HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN 2000000 [iU]/2mL
  • HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2300000 [iU]/2mL
Pharmacological Class(es)
  • Live Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Rotavirus Vaccines - [CS]
  • Vaccines -
  • Live -
  • Unattenuated - [CS]
  • Live Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Rotavirus Vaccines - [CS]
  • Vaccines -
  • Live -
  • Unattenuated - [CS]
  • Live Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Rotavirus Vaccines - [CS]
  • Vaccines -
  • Live -
  • Unattenuated - [CS]
  • Live Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Rotavirus Vaccines - [CS]
  • Vaccines -
  • Live -
  • Unattenuated - [CS]
  • Live Rotavirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Rotavirus Vaccines - [CS]
  • Vaccines -
  • Live -
  • Unattenuated - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category BLA - A product marketed under an approved Biologic License Application. 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.
FDA Application Number BLA125122 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.
Start Marketing Date 02-03-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 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.
Exclude Flag N 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".

NDC Code Structure

  • 0006 - Merck Sharp & Dohme Corp.
    • 0006-4047 - Rotateq
      • 0006-4047-41 - 10 POUCH in 1 CARTON

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.

Other Product Packages

The following packages are also available for Rotateq with product NDC 0006-4047.

NDC Package CodePackage Description
0006-4047-2025 POUCH in 1 CARTON > 1 TUBE in 1 POUCH (0006-4047-02) > 2 mL in 1 TUBE (0006-4047-01)

* Please review the disclaimer below.