Dovato Tablet, Film Coated
NDC Package 49702-246-33

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Dovato (dolutegravir sodium and lamivudine) tablets is this product contains 2 drugs: dolutegravir and lamivudine. This formulation utilizes a tablet, film coated delivery system. Marketed by Viiv Healthcare Company, this product is identified by NDC 49702-246 and is authorized under FDA application NDA211994.

Identification & Billing

NDC Package Code
49702-246-33
Package Description
1 BLISTER PACK in 1 CARTON / 30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
49702-246
11-Digit Billing Format
49702024633
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2122519 - dolutegravir 50 MG / lamiVUDine 300 MG Oral Tablet
  • RxCUI: 2122519 - dolutegravir 50 MG / lamivudine 300 MG Oral Tablet
  • RxCUI: 2122519 - dolutegravir 50 MG (equivalent to 52.6 MG dolutegravir sodium) / lamivudine 300 MG Oral Tablet
  • RxCUI: 2122519 - dolutegravir 50 MG / 3TC 300 MG Oral Tablet
  • RxCUI: 2122526 - Dovato 50 MG / 300 MG Oral Tablet

Clinical Specifications

Proprietary Name
Dovato
Non-Proprietary Name
Dolutegravir Sodium And Lamivudine
Substance Name
Dolutegravir Sodium; Lamivudine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product contains 2 drugs: dolutegravir and lamivudine. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Lamivudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Dolutegravir belongs to a class of drugs known as integrase inhibitors. This medication is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Viiv Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
NDA211994
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-08-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49702-246). Click a package code to view its specific billing and regulatory data.

49702-246-13
30 TABLET, FILM COATED in 1 BOTTLE
49702-246-62
1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49702-246-33 identifies a specific commercial package of 1 blister pack in 1 carton / 30 tablet, film coated in 1 blister pack of Dovato, a human prescription drug labeled by Viiv Healthcare Company. This tablet, film coated is formulated for oral use and contains dolutegravir sodium; lamivudine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viiv Healthcare Company on April 08, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This product contains 2 drugs: dolutegravir and lamivudine. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Lamivudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Dolutegravir belongs to a class of drugs known as integrase inhibitors. This medication is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How is this Viiv Healthcare Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49702024633. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49702-246-33
11-Digit CMS (5-4-2)
49702-0246-33

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.