Prescription drug · NDA
Juluca NDC 49702-242
dolutegravir sodium and rilpivirine hydrochloride · Dolutegravir sodium 50 mg/1; Rilpivirine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-242-13 | 4970202421349702024213 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)Marketed from Nov 21, 2017 |
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)
- Juluca
- Generic name (nonproprietary)
- dolutegravir sodium and rilpivirine hydrochloride
- Active ingredients
- Dolutegravir sodium — 50 mg/1Rilpivirine hydrochloride — 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 210192
- Marketing start
- Listing expires
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 49702-242_19269bd8-a858-414a-80b5-9acba5aa9fd7SPL ID 19269bd8-a858-414a-80b5-9acba5aa9fd7SPL set ID 806653d1-bf35-4924-b999-ad5d21821cc1RxCUI 1989500, 1989506UNII 1Q1V9V5WYQ, 212WAX8KDD
- Pharmacologic class
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor; 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
N449702024213followed by a unit qualifier and the quantityPackage 49702-0242-13. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (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 and no known substitutions associated with resistance to the individual components of JULUCA. JULUCA, a two-drug combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adu…
Excerpt only. Read the full label for complete information.
About NDC 49702-242
- What is NDC 49702-242?
- 49702-242 is the product NDC for Juluca, Dolutegravir sodium 50 mg/1; Rilpivirine hydrochloride 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?
- Juluca (Dolutegravir sodium and rilpivirine hydrochloride).
- What is the active ingredient?
- Dolutegravir sodium, Rilpivirine hydrochloride.
- 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 Juluca?
- 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.