Darunavir Tablet, Film Coated
NDC Package 43598-705-30

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

Darunavir tablets is co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Dr.reddys Laboratories Inc, this product is identified by NDC 43598-705 and is authorized under FDA application ANDA211578.

Identification & Billing

NDC Package Code
43598-705-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
43598-705
11-Digit Billing Format
43598070530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Darunavir
Non-Proprietary Name
Darunavir
Substance Name
Darunavir
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)
DARUNAVIR 800 mg/1
Pharmacologic Class
Usage Information
Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Dr.reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA211578
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2023
Listing Expiration
12-31-2026
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 (43598-705). Click a package code to view its specific billing and regulatory data.

43598-705-05
500 TABLET, FILM COATED in 1 BOTTLE

* 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 43598-705-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Darunavir, a human prescription drug labeled by Dr.reddys Laboratories Inc. This tablet, film coated is formulated for oral use and contains darunavir 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 Dr.reddys Laboratories Inc on November 29, 2023. The current certification is valid through December 31, 2026.

How is this Dr.reddys Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598070530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
43598-705-30
11-Digit CMS (5-4-2)
43598-0705-30

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