Prescription drug · NDA
Tivicay (Dolutegravir sodium) NDC 49702-227
Dolutegravir sodium 25 mg/1 · Tablet, Film coated · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-227-13 | 4970202271349702022713 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)Marketed from Jun 9, 2016 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ViiV Healthcare CompanyNDC labeler code 49702
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204790
- Marketing start
- Marketing end
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 49702-227_5037ffdb-75d0-4abb-bd21-0a1b5920042fSPL ID 5037ffdb-75d0-4abb-bd21-0a1b5920042f
- 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
N449702022713followed by a unit qualifier and the quantityPackage 49702-0227-13. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49702-227
- What is NDC 49702-227?
- 49702-227 is the product NDC for Tivicay (dolutegravir sodium), Dolutegravir sodium 25 mg/1 tablet, film coated, 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?
- Tivicay (Dolutegravir sodium).
- What is the active ingredient?
- Dolutegravir sodium.
- 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 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 50 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-228 | 49702-0228-13 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 50 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-748 | 60760-0748-07 |
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 50 mg/1 | Tablet, Film coatedOral | ViiV Healthcare Company | 49702-228 |
| Tivicaydolutegravir sodium | Dolutegravir sodium 50 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-748 |