Truvada Tablet, Film Coated
NDC Package 61958-0701-1

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

Package Information

Truvada (emtricitabine and tenofovir disoproxil fumarate) 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 Gilead Sciences, Inc, this product is identified by NDC 61958-0701 and is authorized under FDA application NDA021752.

Identification & Billing

NDC Package Code
61958-0701-1
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
61958-0701
11-Digit Billing Format
61958070101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet
  • RxCUI: 1744003 - Truvada 100 MG / 150 MG Oral tablet
  • RxCUI: 1744003 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet [Truvada]
  • RxCUI: 1744003 - Truvada (emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG)) Oral Tablet

Clinical Specifications

Proprietary Name
Truvada
Non-Proprietary Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Substance Name
Emtricitabine; Tenofovir Disoproxil Fumarate
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 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
Gilead Sciences, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021752
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-02-2004
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0750
Source: PREP
Hiv prep, ftc/tdf 200/300mg
HCPCS Dosage 200 MG/300 MG
Units / Pkg 30

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 61958-0701-1 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Truvada, a human prescription drug labeled by Gilead Sciences, Inc. This tablet, film coated is formulated for oral use and contains emtricitabine; tenofovir disoproxil fumarate 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 Gilead Sciences, Inc on August 02, 2004. The current certification is valid through December 31, 2026.

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 Gilead Sciences, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958070101. 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 (5-4-1)
61958-0701-1
11-Digit CMS (5-4-2)
61958-0701-01

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