Rotateq Solution
NDC 0006-4379
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This code was recently added to the official NDC directory and the product has entered commercial distribution.
Rotateq (rotavirus vaccine, live, oral, pentavalent) is a BLA-approved product labeled by Merck Sharp & Dohme Llc. This medication is typically used as a actively acquired immunity [pe]. It is supplied as a solution for oral administration. This product entry covers the primary NDC 0006-4379 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0006-4379
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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
0006
Product Label ID:
FDA Application Number: [6]
BLA125122
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
05-15-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0006-4379?
The NDC code 0006-4379 is assigned by the FDA to the product Rotateq. It is commonly known by its generic name, rotavirus vaccine, live, oral, pentavalent. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-4379-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 Active Ingredients of this product?
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.
- 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
What is the NDC to RxNorm Crosswalk for this product?
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 of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
