NDC 0006-4047 Rotateq

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

Product Information

NDC Product Code:
0006-4047
Proprietary Name:
Rotateq
Non-Proprietary Name: [1]
Rotavirus Vaccine, Live, Oral, Pentavalent
Substance Name: [2]
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
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0006
    FDA Application Number: [6]
    BLA125122
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    02-03-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    PINK (C48328 - PALE YELLOW CLEAR, MAY HAVE A PINK TINT)

    Product Packages

    NDC Code 0006-4047-20

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

    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)

    Product Details

    What is NDC 0006-4047?

    The NDC code 0006-4047 is assigned by the FDA to the product Rotateq which is a vaccine label product labeled by Merck Sharp & Dohme Llc. The generic name of Rotateq is rotavirus vaccine, live, oral, pentavalent. The product's dosage form is solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0006-4047-20 25 pouch in 1 carton / 1 tube in 1 pouch (0006-4047-02) / 2 ml in 1 tube (0006-4047-01), 0006-4047-41 10 pouch in 1 carton / 1 tube in 1 pouch (0006-4047-02) / 2 ml in 1 tube (0006-4047-01). 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 Rotateq?

    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)].

    What are Rotateq Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Rotateq UNII Codes?

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

    • HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN (UNII: 25VC15141Q)
    • HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN (UNII: 25VC15141Q) (Active Moiety)
    • HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN (UNII: JU499IS53H)
    • HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN (UNII: JU499IS53H) (Active Moiety)
    • HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN (UNII: 236YGP181O)
    • HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN (UNII: 236YGP181O) (Active Moiety)
    • HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN (UNII: 6334XMP4KC)
    • HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN (UNII: 6334XMP4KC) (Active Moiety)
    • HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN (UNII: L1977Q86S5)
    • HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN (UNII: L1977Q86S5) (Active Moiety)

    Which are Rotateq 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 Rotateq?

    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: 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]

    Which are the Pharmacologic Classes for Rotateq?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [11] 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.

    [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".