Cabenuva Kit
NDC 49702-266
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Cabenuva (cabotegravir and rilpivirine) is a NDA-approved product labeled by Viiv Healthcare Company. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 49702-266 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
49702-266
Proprietary Name:
Cabenuva
Non-Proprietary Name: [1]
Cabotegravir And Rilpivirine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
49702
Product Label ID:
FDA Application Number: [6]
NDA212888
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-21-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 49702-266?
The NDC code 49702-266 is assigned by the FDA to the product Cabenuva. It is commonly known by its generic name, cabotegravir and rilpivirine. This pharmaceutical product is labeled by Viiv Healthcare Company and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49702-266-63. 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?
CABENUVA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Clinical Studies (14.1)].
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: 2475415 - {1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack
- RxCUI: 2475415 - cabotegravir 600 MG / rilpivirine 900 MG Extended Release Kit
- RxCUI: 2475416 - {1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 600 MG / 900 MG]
- RxCUI: 2475416 - CABENUVA 600 MG / 900 MG Extended Release Kit
- RxCUI: 2475417 - {1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } Pack
* Please review the full disclaimer at the bottom of this page.
Patient Education
Cabotegravir and Rilpivirine Injections
Cabotegravir and rilpivirine injections are used in combination for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in certain adults and children 12 years of age or older weighing at least 77 pounds (35 kg). Cabotegravir is in a class of medications called HIV integrase inhibitors. Rilpivirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). These medications work by decreasing the amount of HIV in the blood. Although cabotegravir and rilpivirine do not cure HIV, they may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Receiving these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.
[Learn More]
Cabotegravir injection
Cabotegravir injection is used for prevention of human immunodeficiency virus type 1 (HIV-1) infection in certain adults and adolescents 12 years of age or older weighing at least 77 pounds (35 kg).
[Learn More]
* Please review the full disclaimer at the bottom of this page.
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 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 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".
