Darunavir Tablet, Film Coated
NDC Package 68180-346-06

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

Package Information

Darunavir tablets is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a tablet, film coated delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-346 and is authorized under FDA application ANDA202073.

Identification & Billing

NDC Package Code
68180-346-06
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
68180-346
11-Digit Billing Format
68180034606
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 Ethanolate
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 ETHANOLATE 800 mg/1
Pharmacologic Class
Usage Information
This drug is used with other HIV medications 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202073
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68180-346-06 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Darunavir, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains darunavir ethanolate 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 Lupin Pharmaceuticals, Inc. on June 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used with other HIV medications 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180034606. 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)
68180-346-06
11-Digit CMS (5-4-2)
68180-0346-06

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