Symfi Lo
NDC Package 49502-425-93

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.

Symfi Lo is this combination product is used by itself to help control HIV infection. Marketed by Viatris Specialty Llc, this product is identified by NDC 49502-425 and is authorized under FDA application NDA208255.

Identification & Billing

NDC Package Code
49502-425-93
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
49502042593
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Symfi Lo
Dosage Form
-
Usage Information
This combination product is used by itself 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 3 different drugs: efavirenz, lamivudine, and tenofovir. Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Lamivudine is called a nucleoside reverse transcriptase inhibitor and tenofovir is called a nucleotide reverse transcriptase inhibitor. Lamivudine and tenofovir are often called NRTIs. Efavirenz/lamivudine/tenofovir 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
Viatris Specialty Llc
FDA Application #
NDA208255
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-13-2018
End Marketing Date
10-31-2025
Listing Expiration
10-31-2025
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 49502-425-93 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 tablet, film coated in 1 bottle, plastic of Symfi Lo, labeled by Viatris Specialty Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Viatris Specialty Llc on March 13, 2018. The current certification is valid through October 31, 2025.

What are the primary indications for this medication?

This combination product is used by itself 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 3 different drugs: efavirenz, lamivudine, and tenofovir. Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Lamivudine is called a nucleoside reverse transcriptase inhibitor and tenofovir is called a nucleotide reverse transcriptase inhibitor. Lamivudine and tenofovir are often called NRTIs. Efavirenz/lamivudine/tenofovir 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 Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49502042593. 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)
49502-425-93
11-Digit CMS (5-4-2)
49502-0425-93

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