Home NDC 61958-1901 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207561-001 GENVOYA COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207561-001 7176220 2026-08-27 U-257 Drug substance, Drug product 2015-12-01 N207561-001 7635704 2026-10-26 U-257 Drug substance, Drug product 2015-12-01 N207561-001 8981103 2026-10-26 Drug substance, Drug product 2015-12-01 N207561-001 7176220*PED 2027-02-27 Pediatric extension N207561-001 7635704*PED 2027-04-26 Pediatric extension N207561-001 8981103*PED 2027-04-26 Pediatric extension N207561-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-12-01 N207561-001 9891239 2029-09-03 U-257 Drug product 2018-02-27 N207561-001 8148374*PED 2030-03-03 Pediatric extension N207561-001 9891239*PED 2030-03-03 Pediatric extension N207561-001 8633219 2030-04-30 U-257 Drug product 2015-12-01 N207561-001 8633219*PED 2030-10-30 Pediatric extension N207561-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2015-12-01 N207561-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-22 N207561-001 10039718 2032-10-06 Drug product 2018-08-28 N207561-001 8754065*PED 2033-02-15 Pediatric extension N207561-001 9296769*PED 2033-02-15 Pediatric extension N207561-001 10039718*PED 2033-04-06 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207561-001 GENVOYA 150MG;150MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2015-11-05 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 21 · 805 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N207561-001 7176220 2026-08-27 U-257 Drug substance, Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 7635704 2026-10-26 U-257 Drug substance, Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8981103 2026-10-26 Drug substance, Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 7176220*PED 2027-02-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 7635704*PED 2027-04-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8981103*PED 2027-04-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 9891239 2029-09-03 U-257 Drug product 2018-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8148374*PED 2030-03-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 9891239*PED 2030-03-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8633219 2030-04-30 U-257 Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8633219*PED 2030-10-30 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2015-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 10039718 2032-10-06 Drug product 2018-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 8754065*PED 2033-02-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 9296769*PED 2033-02-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207561-001 10039718*PED 2033-04-06 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207561-001 7176220 2026-08-27 U-257 Drug substance, Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 7635704 2026-10-26 U-257 Drug substance, Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8981103 2026-10-26 Drug substance, Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 7176220*PED 2027-02-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 7635704*PED 2027-04-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8981103*PED 2027-04-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 9891239 2029-09-03 U-257 Drug product 2018-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 9891239*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8633219 2030-04-30 U-257 Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8633219*PED 2030-10-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2015-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2016-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 10039718 2032-10-06 Drug product 2018-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207561-001 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207561-001 7390791 2025-01-07 Drug substance, Drug product 2015-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207561-001 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207561-001 7176220 2026-08-27 U-257 Drug substance, Drug product 2015-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207561-001 7635704 2026-10-26 U-257 Drug substance, Drug product 2015-12-01 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Genvoya
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELVITEGRAVIR 150 mg/1 COBICISTAT 150 mg/1 EMTRICITABINE 200 mg/1 TENOFOVIR ALAFENAMIDE FUMARATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721613 Internal RxNorm lookup 1721619 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-1901-1 Genvoya 30 in 1 BOTTLE, PLASTIC TABLET 30 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cobicistat ACTIVE INGREDIENT LW2E03M5PG GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 elvitegravir ACTIVE INGREDIENT 4GDQ854U53 GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 emtricitabine ACTIVE INGREDIENT G70B4ETF4S GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 tenofovir alafenamide fumarate ACTIVE INGREDIENT FWF6Q91TZO GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 cobicistat ACTIVE MOIETY LW2E03M5PG GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 elvitegravir ACTIVE MOIETY 4GDQ854U53 GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 emtricitabine ACTIVE MOIETY G70B4ETF4S GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 tenofovir alafenamide ACTIVE MOIETY EL9943AG5J GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Genvoya ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE Gilead Sciences, Inc. 34784acf-15ed-4715-b504-eb30430518e9 2025-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207561 application number: NDA207561 ndc (product): 61958-1901
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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