Prescription drug · NDA
Tivicay PD (Dolutegravir sodium) NDC 49702-255
Dolutegravir sodium 5 mg/1 · Tablet, For suspension · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-255-37 | 49702025537 | 1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLEMarketed from Jun 12, 2020 |
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 PD
- Generic name (nonproprietary)
- dolutegravir sodium
- Active ingredients
- Dolutegravir sodium — 5 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- ViiV Healthcare CompanyNDC labeler code 49702
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213983
- 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 49702-255_edfff6ba-b810-49ff-a578-f03b9544e886SPL ID edfff6ba-b810-49ff-a578-f03b9544e886SPL set ID 63df5af3-b8ac-4e76-9830-2dbb340af922RxCUI 1433873, 1433879, 1796077, 1796079, 1796081, 1796083, 2374562, 2374566UNII 1Q1V9V5WYQUPC 0349702227132, 0349702226135, 0349702228139
- 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
N449702025537followed by a unit qualifier and the quantityPackage 49702-0255-37. 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) weighing at least 2 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 known substitutions assoc…
Excerpt only. Read the full label for complete information.
About NDC 49702-255
- What is NDC 49702-255?
- 49702-255 is the product NDC for Tivicay PD (dolutegravir sodium), Dolutegravir sodium 5 mg/1 tablet, for suspension, 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 PD (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 PD?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.