NDC codes

FDA NDC Directory
Product NDC (as listed)49702-242Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49702-0242Add 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
49702-242-13497020242134970202421330 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

N449702024213 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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