Prescription drug · NDA
Apretude (Cabotegravir) NDC 49702-280
Kit · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-280-63 | 49702028063 | 1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61)Marketed from Mar 31, 2024 · 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)
- Apretude
- Generic name (nonproprietary)
- cabotegravir
- Dosage form
- Kit
- Labeler
- ViiV Healthcare CompanyNDC labeler code 49702
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215499
- Marketing start
- Listing expires
- Identifiers
- Product ID 49702-280_cedc4b34-5c83-4d5f-a47f-7d5e93f71459SPL ID cedc4b34-5c83-4d5f-a47f-7d5e93f71459SPL set ID 4338428e-43d4-4e02-ac9d-bd98e738a7daRxCUI 2588077, 2588080
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
N449702028063followed by a unit qualifier and the quantityPackage 49702-0280-63. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
APRETUDE is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection 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 APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP [see Dosage and Administration ( 2.2 , 2.4 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . APRETUDE is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must…
Excerpt only. Read the full label for complete information.
About NDC 49702-280
- What is NDC 49702-280?
- 49702-280 is the product NDC for Apretude (cabotegravir) kit, listed with the FDA by ViiV Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Apretude (Cabotegravir).
- Who is the labeler?
- ViiV Healthcare Company, NDC labeler code 49702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Apretude?
- 1 other product NDC are listed under this name. See all Apretude NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Apretude products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Apretudecabotegravir | — | Kit | ViiV Healthcare Company | 49702-264 | 49702-0264-23 |
Other NDCs under NDA 215499
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Apretudecabotegravir | — | Kit | ViiV Healthcare Company | 49702-264 |