Prescription drug · ANDA
Etravirine NDC 80005-112
Etravirine 100 mg/1 · Tablet · Oral · Carnegie Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-112-12 | 80005011212 | 120 TABLET in 1 BOTTLE (80005-112-12)Marketed from Jun 7, 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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Carnegie Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215402
- 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 80005-112_4b21f36b-78b4-41db-ae59-814076cf5b90SPL ID 4b21f36b-78b4-41db-ae59-814076cf5b90SPL set ID 154b621d-9a72-489f-9127-55f9bf1797a0RxCUI 754761, 1052658UNII 0C50HW4FO1UPC 0380005113098, 0380005112121
- 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
N480005011212followed by a unit qualifier and the quantityPackage 80005-0112-12. 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 ANDA 215402
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 | Leading Pharma, LLC | 69315-286 |
| Etravirine | Etravirine 100 mg/1 | TabletOral | Leading Pharma, LLC | 69315-285 |
| Etravirine | Etravirine 200 mg/1 | TabletOral | Carnegie Pharmaceuticals LLC | 80005-113 |