Prescription drug · NDA
Sunlenca (Lenacapavir sodium) NDC 61958-3001
Lenacapavir sodium 300 mg/1 · Tablet, Film coated · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-3001-1 | 6195830010161958300101 | 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 22, 2022 | |
| 61958-3001-2 | 6195830010261958300102 | 1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 22, 2022 | |
| 61958-3001-3 | 6195830010361958300103 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)Marketed from Nov 13, 2024 |
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)
- Sunlenca
- Generic name (nonproprietary)
- lenacapavir sodium
- Active ingredients
- Lenacapavir sodium — 300 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 215974
- 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 61958-3001_142b440e-6eae-4d76-8312-b094de1380c3SPL ID 142b440e-6eae-4d76-8312-b094de1380c3SPL set ID e5652804-29c4-40d7-aeb2-0142ed2a7b5bRxCUI 2625890, 2625896, 2625897, 2625898, 2625899, 2625900, 2625904, 2625909, 2625911, 2625912UNII 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
N461958300101followed by a unit qualifier and the quantityPackage 61958-3001-01. 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)
SUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations. ( 1.1 ) for oral loading as a component of the initiation regimen for BIXLENVO (bictegravir [BIC]/lenacapavir [LEN]), a complete regimen for the treatment of 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 n…
Excerpt only. Read the full label for complete information.
About NDC 61958-3001
- What is NDC 61958-3001?
- 61958-3001 is the product NDC for Sunlenca (lenacapavir sodium), Lenacapavir sodium 300 mg/1 tablet, film coated, listed with the FDA by Gilead Sciences, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sunlenca (Lenacapavir sodium).
- What is the active ingredient?
- 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 Sunlenca?
- 2 other product NDCs are listed under this name. See all Sunlenca NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sunlenca products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sunlencalenacapavir sodium | — | Kit | Gilead Sciences, Inc. | 61958-3005 | 61958-3005-01 |
| Sunlencalenacapavir sodium | — | Kit | Gilead Sciences, Inc. | 61958-3002 | 61958-3002-01 |