Prescription drug · ANDA
etravirine NDC 60219-1720
Etravirine 25 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1720-7 | 60219172007 | 120 TABLET in 1 BOTTLE, PLASTIC (60219-1720-7)Marketed from Jun 14, 2021 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214196
- 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 60219-1720_d93c4af1-6f7d-4744-8b1e-21d89a5f5c9bSPL ID d93c4af1-6f7d-4744-8b1e-21d89a5f5c9bSPL set ID 4e009f19-4609-4020-bee1-dc27c504046cRxCUI 754761, 1052658, 1250721UNII 0C50HW4FO1UPC 0360219172074
- 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
N460219172007followed by a unit qualifier and the quantityPackage 60219-1720-07. 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 tablets, in combination with other antiretroviral agents, are 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 214196
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 100 mg/1 | TabletOral | AvKARE | 42291-473 |
| etravirine | Etravirine 200 mg/1 | TabletOral | AvKARE | 42291-474 |
| etravirine | Etravirine 100 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-1721 |
| etravirine | Etravirine 200 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-1722 |