Prescription drug · NDA
Cabenuva NDC 49702-266
cabotegravir and rilpivirine · Kit · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-266-63 | 49702026663 | 1 KIT in 1 CARTON (49702-266-63) * 3 mL in 1 VIAL (49702-238-64) * 3 mL in 1 VIAL (49702-243-61)Marketed from Jan 21, 2025 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Cabenuva
- Generic name (nonproprietary)
- cabotegravir and rilpivirine
- Dosage form
- Kit
- Labeler
- ViiV Healthcare Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212888
- Marketing start
- Listing expires
- Identifiers
- Product ID 49702-266_15253b2a-c96c-489c-be6d-b37fcb63ad5bSPL ID 15253b2a-c96c-489c-be6d-b37fcb63ad5bSPL set ID 1698baf3-f895-4c42-a1b1-e9ee3f20da36RxCUI 2475415, 2475416, 2475417, 2475418, 2588077, 2594978, 2594980, 2594982
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
N449702026663followed by a unit qualifier and the quantityPackage 49702-0266-63. 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)
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine [see Microbiology ( 12.4 ), Clinical Studies ( 14.1 )] . CABENUVA, a 2-drug co-packaged product of cabotegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non‑nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a comple…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212888
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.