Truvada
NDC Package 35356-070-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Truvada is a medication used with other HIV medications to help control HIV infection. Marketed by Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 35356-070 and is authorized under FDA application NDA021752.

Identification & Billing

NDC Package Code
35356-070-03
Package Description
3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
35356007003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

Clinical Specifications

Proprietary Name
Truvada
Dosage Form
-
Usage Information
This product 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. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and 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
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
NDA021752
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-02-2004
End Marketing Date
10-11-2019
Listing Expiration
10-11-2019
Exclude Flag
D
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 35356-070-03 identifies a specific commercial package of 3 tablet, film coated in 1 bottle, plastic of Truvada, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lake Erie Medical Dba Quality Care Products Llc on August 02, 2004. The current certification is valid through October 11, 2019.

What are the primary indications for this medication?

This product 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. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and 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 Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356007003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
35356-070-03
11-Digit CMS (5-4-2)
35356-0070-03

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