Intelence (etravirine) NDC 59676-571

NDC codes

FDA NDC Directory

Product NDC (as listed)59676-571Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59676-0571Add 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 NDC	11-digit (billing)	Package	Copy
59676-571-01	59676057101	60 TABLET in 1 BOTTLE, PLASTIC (59676-571-01)Marketed from Dec 22, 2010

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): Intelence
Generic name (nonproprietary): etravirine
Active ingredients: Etravirine — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Janssen Products LP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022187
Marketing start: Dec 22, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 59676-571_02fc6f4f-330d-b32e-e063-6294a90a028aSPL ID 02fc6f4f-330d-b32e-e063-6294a90a028aSPL set ID 6a9cbc29-9f15-4b24-8d86-206b82887f3dRxCUI 754761, 758555, 1052658, 1052660, 1250721, 1250723UNII 0C50HW4FO1UPC 0359676570011, 0359676571018, 0359676572015
Pharmacologic class: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase 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

N459676057101 followed by a unit qualifier and the quantity

Package 59676-0571-01. 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 Aug 15, 2023.

Indications (excerpt from the label)

INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] . INTELENCE is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022187

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022187
Product	Strength	Form · route	Labeler	Product NDC
Etravirine	Etravirine 100 mg/1	TabletOral	Patriot Pharmaceuticals	10147-0570
Etravirine	Etravirine 200 mg/1	TabletOral	Patriot Pharmaceuticals	10147-0571
Intelenceetravirine	Etravirine 100 mg/1	TabletOral	Janssen Products LP	59676-570
Intelenceetravirine	Etravirine 25 mg/1	TabletOral	Janssen Products LP	59676-572