Prescription drug · NDA
Genvoya NDC 61958-1901
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide · Elvitegravir 150 mg/1 + 3 more ingredients · Tablet · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-1901-1 | 61958190101 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)Marketed from Nov 5, 2015 |
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)
- Genvoya
- Generic name (nonproprietary)
- elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
- Active ingredients
- Elvitegravir — 150 mg/1Cobicistat — 150 mg/1Emtricitabine — 200 mg/1Tenofovir alafenamide fumarate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207561
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7SPL ID 7bb9d232-d878-47d0-8262-abc4d06b37f7SPL set ID 34784acf-15ed-4715-b504-eb30430518e9RxCUI 1721613, 1721619UNII 4GDQ854U53, LW2E03M5PG, G70B4ETF4S, FWF6Q91TZO
- Pharmacologic class
- Cytochrome P450 3A Inhibitor; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor; Human Immunodeficiency Virus 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
N461958190101followed by a unit qualifier and the quantityPackage 61958-1901-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA [see Clinical Studies (14) ]. GENVOYA is a four-drug combination of elvitegravir (EVG), an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (F…
Excerpt only. Read the full label for complete information.