Symfi Lo
NDC Package 49502-425-93
Package Information
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
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 49502 - Viatris Specialty Llc
- 49502-425 - Symfi Lo
- 49502-425-93 - 1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 49502-425 - Symfi Lo
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.
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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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.