Sunlenca (lenacapavir sodium) NDC 61958-3001

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-3001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-3001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
61958-3001-1	61958300101	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	61958300102	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	61958300103	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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215974
Marketing start: Dec 22, 2022
Listing expires: Dec 31, 2027
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

N461958300101 followed by a unit qualifier and the quantity

Package 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 Aug 27, 2026.

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.

Full label on DailyMed (opens in a new tab)