Prescription drug · NDA
Tivicay (Dolutegravir sodium) NDC 60760-748
Dolutegravir sodium 50 mg/1 · Tablet, Film coated · Oral · ST. MARY'S MEDICAL PARK PHARMACY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-748-07 | 6076007480760760074807 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07)Marketed from Jan 16, 2026 |
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)
- Tivicay
- Generic name (nonproprietary)
- dolutegravir sodium
- Active ingredients
- Dolutegravir sodium — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACYNDC labeler code 60760
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204790
- Marketing start
- Listing expires
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 60760-748_526982bc-f7b7-0c37-e063-6394a90a6d6fSPL ID 526982bc-f7b7-0c37-e063-6394a90a6d6fSPL set ID 485bc9db-8665-9f5a-e063-6394a90a7921RxCUI 1433873, 1433879UNII 1Q1V9V5WYQ
- Pharmacologic class
- Human Immunodeficiency Virus Integrase Strand Transfer 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
N460760074807followed by a unit qualifier and the quantityPackage 60760-0748-07. 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)
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )]. TIVICAY is indicated in combination with rilpivirine as 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/ mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or…
Excerpt only. Read the full label for complete information.
About NDC 60760-748
- What is NDC 60760-748?
- 60760-748 is the product NDC for Tivicay (dolutegravir sodium), Dolutegravir sodium 50 mg/1 tablet, film coated, listed with the FDA by ST. MARY'S MEDICAL PARK PHARMACY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tivicay (Dolutegravir sodium).
- What is the active ingredient?
- Dolutegravir sodium.
- Who is the labeler?
- ST. MARY'S MEDICAL PARK PHARMACY, NDC labeler code 60760. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tivicay?
- 3 other product NDCs are listed under this name. See all Tivicay NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tivicay products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tivicaydolutegravir sodium | Dolutegravir sodium 10 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-226 | 49702-0226-13 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 25 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-227 | 49702-0227-13 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 50 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-228 | 49702-0228-13 |
Other NDCs under NDA 204790
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 |
|---|---|---|---|---|
| Tivicaydolutegravir sodium | Dolutegravir sodium 10 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-226 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 25 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-227 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 50 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-228 |