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NDC 49702-258 Triumeq Pd

Abacavir Sulfate,Dolutegravir Sodium,Lamivudine Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49702-258?
  4. Triumeq Pd Uses
  5. NDC to RxNorm Crosswalk
  6. Patient Education

Product Information

NDC Product Code:
49702-258
Proprietary Name:
Triumeq Pd
Non-Proprietary Name: [1]
Abacavir Sulfate, Dolutegravir Sodium, Lamivudine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Viiv Healthcare Company
Labeler Code:
49702
Product Label ID:
2997739a-aa91-42aa-a206-a70e2db7b84f
FDA Application Number: [6]
NDA215413
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
03-30-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 49702-258?

The NDC code 49702-258 is assigned by the FDA to the product Triumeq Pd which is a human prescription drug product labeled by Viiv Healthcare Company. The generic name of Triumeq Pd is abacavir sulfate, dolutegravir sodium, lamivudine. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 49702-258-37 1 kit in 1 carton * 90 tablet, film coated in 1 bottle (49702-272-59). 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 Triumeq Pd?

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.Limitations of Use:•TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir).

What is the NDC to RxNorm Crosswalk for Triumeq Pd?

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: 1546888 - abacavir 600 MG / dolutegravir 50 MG / lamiVUDine 300 MG Oral Tablet
  • RxCUI: 1546888 - abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral Tablet
  • RxCUI: 1546888 - abacavir 600 MG / dolutegravir 50 MG / 3TC 300 MG Oral Tablet
  • RxCUI: 1546894 - Triumeq 600 MG / 50 MG / 300 MG Oral Tablet
  • RxCUI: 1546894 - abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral Tablet [Triumeq]

* Please review the disclaimer below.

Patient Education

Abacavir, Dolutegravir, and Lamivudine


The combination of abacavir, dolutegravir, and lamivudine is used alone or along with other medications to treat HIV infection in certain adults and children who weigh at least 88 lb (40 kg). Abacavir and lamivudine are in a class of medications called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and dolutegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). They work by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. Although abacavir, dolutegravir, and lamivudine will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.
[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.

[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.

[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".