What is NDC 69315-286?

69315-286 is the product NDC for Etravirine, Etravirine 200 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Etravirine?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Etravirine NDC 69315-286 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-286Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0286Add 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
69315-286-06	6931502860669315028606	60 TABLET in 1 BOTTLE (69315-286-06)Marketed from Jun 5, 2022

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): Etravirine
Generic name (nonproprietary): etravirine
Active ingredients: Etravirine — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215402
Marketing start: Jun 5, 2022
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 69315-286_f356d1ba-3572-4a79-9846-94ee2030f04bSPL ID f356d1ba-3572-4a79-9846-94ee2030f04bSPL set ID 48ffeac8-38e8-4007-903a-dbffce25d679RxCUI 754761, 1052658UNII 0C50HW4FO1
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

N469315028606 followed by a unit qualifier and the quantity

Package 69315-0286-06. 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 Jan 10, 2024.

Indications (excerpt from the label)

Etravirine, 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) ] Etravirine 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)

About NDC 69315-286

What is NDC 69315-286?: 69315-286 is the product NDC for Etravirine, Etravirine 200 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Etravirine.
What is the active ingredient?: Etravirine.
Who is the labeler?: Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Etravirine?: 12 other product NDCs are listed under this name. See all Etravirine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Etravirine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
etravirine	Etravirine 100 mg/1	TabletOral	Bionpharma Inc.	69452-254	69452-0254-22
etravirine	Etravirine 200 mg/1	TabletOral	Bionpharma Inc.	69452-255	69452-0255-17
Etravirine	Etravirine 100 mg/1	TabletOral	Patriot Pharmaceuticals	10147-0570	10147-0570-01
Etravirine	Etravirine 200 mg/1	TabletOral	Patriot Pharmaceuticals	10147-0571	10147-0571-01
etravirine	Etravirine 100 mg/1	TabletOral	AvKARE	42291-473	42291-0473-12
etravirine	Etravirine 200 mg/1	TabletOral	AvKARE	42291-474	42291-0474-60
Etravirine	Etravirine 100 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-112	80005-0112-12
Etravirine	Etravirine 200 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-113	80005-0113-09
Etravirine	Etravirine 100 mg/1	TabletOral	Leading Pharma, LLC	69315-285	69315-0285-20
etravirine	Etravirine 25 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-1720	60219-1720-07

All 13 Etravirine NDCs

Other NDCs under ANDA 215402

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

FDA NDC Directory listings under ANDA 215402
Product	Strength	Form · route	Labeler	Product NDC
Etravirine	Etravirine 100 mg/1	TabletOral	Leading Pharma, LLC	69315-285
Etravirine	Etravirine 100 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-112
Etravirine	Etravirine 200 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-113