Prescription drug · NDA
Yeztugo (Lenacapavir sodium) NDC 61958-3402
Kit · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-3402-1 | 6195834020161958340201 | 1 KIT in 1 CARTON (61958-3402-1) * 1.5 mL in 1 VIAL (61958-3403-1)Marketed from Jun 18, 2025 |
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)
- Yeztugo
- Generic name (nonproprietary)
- lenacapavir sodium
- Dosage form
- Kit
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220018
- Marketing start
- Listing expires
- Identifiers
- Product ID 61958-3402_557388f0-4c3d-4fee-9bc8-72b035775b2eSPL ID 557388f0-4c3d-4fee-9bc8-72b035775b2eSPL set ID 1c241af1-ce62-4b0a-9eb7-f6b626174f01RxCUI 2625890, 2625904, 2625911, 2717197, 2717201, 2717203UNII BDT58WJ9WE
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N461958340201followed by a unit qualifier and the quantityPackage 61958-3402-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
YEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. YEZTUGO, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 61958-3402
- What is NDC 61958-3402?
- 61958-3402 is the product NDC for Yeztugo (lenacapavir sodium) kit, 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?
- Yeztugo (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 Yeztugo?
- 1 other product NDC are listed under this name. See all Yeztugo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Yeztugo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Yeztugolenacapavir sodium | Lenacapavir sodium 300 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc. | 61958-3401 | 61958-3401-01 |