NDC codes

FDA NDC Directory
Product NDC (as listed)49702-255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49702-0255Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49702-255-37497020255371 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

N449702025537 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in