Genvoya

Product NDC: 70518-0568
Requested package NDC: 70518-0568-0
11-digit product format: 705180568
Labeler code: 70518
Product ID: 70518-0568_d83766b4-2e3d-14d3-e053-2a95a90a80db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA207561
Marketing category: NDA
Marketing start: 2017-06-06
Marketing end: 0000-00-00
Substance: COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 150 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], 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0568	70518-0568-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207561-001	NPP	2020-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207561-001	NCE	2020-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207561-001	D-173	2021-12-10	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207561-001	D-173	2021-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207561-001	D-173	2021-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207561-001	D-173	2021-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207561-001	NPP	2020-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207561-001	NCE	2020-11-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207561-001	D-173	2021-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207561-001	NPP	2020-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207561-001	NCE	2020-11-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207561-001	D-173	2021-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207561-001	NPP	2020-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207561-001	NCE	2020-11-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207561-001	D-173	2021-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207561-001	NPP	2020-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207561-001	NCE	2020-11-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207561-001	D-173	2021-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207561-001	NPP	2020-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207561-001	NCE	2020-11-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207561-001	D-173	2021-12-10	`ea99ee380514…`

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LW2E03M5PG	COBICISTAT	1004316-88-4	COBICISTAT
4GDQ854U53	ELVITEGRAVIR	697761-98-1	ELVITEGRAVIR
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
FWF6Q91TZO	TENOFOVIR ALAFENAMIDE FUMARATE	1392275-56-7	TENOFOVIR ALAFENAMIDE FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0568-0	70518056800	30 TABLET in 1 BLISTER PACK (70518-0568-0)	30 tablet	2017-06-06	0000-00-00	No	No	Current