Genvoya
- Product NDC
- 61958-1901
- 11-digit product format
- 619581901
- Labeler code
- 61958
- Product ID
- 61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA207561
- Marketing category
- NDA
- Marketing start
- 2015-11-05
- Substance
- COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
- Active strength
- 150; 150; 200; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], HIV Integrase Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Genvoya
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| COBICISTAT | 150 mg/1 |
| ELVITEGRAVIR | 150 mg/1 |
| EMTRICITABINE | 200 mg/1 |
| TENOFOVIR ALAFENAMIDE FUMARATE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | LW2E03M5PG, 4GDQ854U53, G70B4ETF4S, FWF6Q91TZO |
| Rxcui | 1721613, 1721619 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61958-1901-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2ab2-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use GENVOYA safely and effectively. See full prescribing information for GENVOYA. GENVOYA ® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61958-1901-1 | Genvoya | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61958-1901-1 | EA - Each | 61958-1901 | d979311b-fa08-420f-87fd-7a300cdacc63 | 1 | 2015-12-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61958-1901 | GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20250205_34784acf-15ed-4715-b504-eb30430518e9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1721613 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet | PSN | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
| 1721619 | Genvoya 150 MG / 150 MG / 200 MG / 10 MG Oral Tablet | PSN | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
| 1721619 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet [Genvoya] | SBD | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
| 1721613 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet | SCD | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
| 1721613 | cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG (as tenofovir alafenamide fumarate 11.2 MG) Oral Tablet | SY | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
| 1721619 | Genvoya (cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG (as tenofovir alafenamide fumarate 11.2 MG)) Oral Tablet | SY | 34784acf-15ed-4715-b504-eb30430518e9 | 22 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61958-1901-1 | 61958190101 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1) | 30 tablet | 2015-11-05 | 0000-00-00 | No | No | Current |