Prescription drug · NDA
Etravirine NDC 10147-0570
Etravirine 100 mg/1 · Tablet · Oral · Patriot Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10147-0570-1 | 10147057001 | 120 TABLET in 1 BOTTLE, PLASTIC (10147-0570-1)Marketed from Apr 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Patriot Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022187
- Marketing start
- Listing expires
- 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 10147-0570_31cddc7a-0154-c49a-e063-6394a90a1a49SPL ID 31cddc7a-0154-c49a-e063-6394a90a1a49SPL set ID 50ca19cb-0f43-4d7b-8c9e-8b3aaded0546RxCUI 754761, 1052658UNII 0C50HW4FO1UPC 0310147057110, 0310147057011
- 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
N410147057001followed by a unit qualifier and the quantityPackage 10147-0570-01. 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 .
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.
Other NDCs under NDA 022187
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Etravirine | Etravirine 200 mg/1 | TabletOral | Patriot Pharmaceuticals | 10147-0571 |
| Intelenceetravirine | Etravirine 100 mg/1 | TabletOral | Janssen Products LP | 59676-570 |
| Intelenceetravirine | Etravirine 200 mg/1 | TabletOral | Janssen Products LP | 59676-571 |
| Intelenceetravirine | Etravirine 25 mg/1 | TabletOral | Janssen Products LP | 59676-572 |