Prescription drug · NDA
Bixlenvo (Bictegravir/lenacapavir) NDC 61958-3601
Bictegravir sodium 75 mg/1; Lenacapavir sodium 50 mg/1 · Tablet, Film coated · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-3601-1 | 6195836010161958360101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-1)Marketed from Aug 27, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bixlenvo
- Generic name (nonproprietary)
- bictegravir/lenacapavir
- Active ingredients
- Bictegravir sodium — 75 mg/1Lenacapavir sodium — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 221104
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Capsid Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 61958-3601_1da44bad-4470-4f3d-b7b2-bc3730f496d1SPL ID 1da44bad-4470-4f3d-b7b2-bc3730f496d1SPL set ID 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48RxCUI 2750177, 2750183UNII 4L5MP1Y7W7, BDT58WJ9WE
- Pharmacologic class
- Human Immunodeficiency Virus 1 Capsid Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461958360101followed by a unit qualifier and the quantityPackage 61958-3601-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO [see Clinical Studies (14) ] . BIXLENVO, a two-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and lenacapavir (LEN), an HIV-1 capsid inhibitor, is indicated as a complete regimen for the treatment of HIV-1 in adults to replace the current antiretr…
Excerpt only. Read the full label for complete information.
About NDC 61958-3601
- What is NDC 61958-3601?
- 61958-3601 is the product NDC for Bixlenvo (bictegravir/lenacapavir), Bictegravir sodium 75 mg/1; Lenacapavir sodium 50 mg/1 tablet, film coated, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bixlenvo (Bictegravir/lenacapavir).
- What is the active ingredient?
- Bictegravir sodium, Lenacapavir sodium.
- Who is the labeler?
- Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bixlenvo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.