Stribild

Product NDC: 69189-1201
11-digit product format: 691891201
Labeler code: 69189
Product ID: 69189-1201_ba8255c3-a4e3-4e8d-97bd-27c4b018c553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA203100
Marketing category: NDA
Marketing start: 2015-10-28
Marketing end: 0000-00-00
Substance: ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 150 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69189-1201		I	Inactivated by FDA		2026-08-11
excluded package	package	69189-1201	69189-1201-1	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69189-1201-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69189-1201-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69189-1201-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-1201-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-1201-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-1201-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-1201-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-1201-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-1201-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-1201-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-1201-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-1201-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-1201-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-1201-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-1201-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-1201-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-1201-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-1201-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-1201-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69189-1201-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-1201-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-1201-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N203100-001	STRIBILD	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	150MG;150MG;200MG;300MG	TABLET / ORAL		RLD, RS	2012-08-27

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203100-001	7176220	2026-08-27	U-257	Drug substance, Drug product
N203100-001	7635704	2026-10-26	U-257	Drug substance, Drug product
N203100-001	8981103	2026-10-26		Drug substance, Drug product	2015-04-14
N203100-001	7176220*PED	2027-02-27		Pediatric extension
N203100-001	7635704*PED	2027-04-26		Pediatric extension
N203100-001	8981103*PED	2027-04-26		Pediatric extension
N203100-001	8148374	2029-09-03	U-1279	Drug substance, Drug product
N203100-001	9891239	2029-09-03	U-257	Drug product	2018-03-06
N203100-001	8148374*PED	2030-03-03		Pediatric extension
N203100-001	9891239*PED	2030-03-03		Pediatric extension
N203100-001	8633219	2030-04-30	U-257	Drug product	2014-01-24
N203100-001	8633219*PED	2030-10-30		Pediatric extension
N203100-001	10039718	2032-10-06		Drug product	2018-09-04
N203100-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203100-001	STRIBILD	150MG;150MG;200MG;300MG	TABLET / ORAL	RLD, RS	2012-08-27	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 691 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203100-001	7176220	2026-08-27	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	7635704	2026-10-26	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8981103	2026-10-26		Drug substance, Drug product	2015-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	7176220*PED	2027-02-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	7635704*PED	2027-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8981103*PED	2027-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8148374	2029-09-03	U-1279	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	9891239	2029-09-03	U-257	Drug product	2018-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8148374*PED	2030-03-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	9891239*PED	2030-03-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8633219	2030-04-30	U-257	Drug product	2014-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	8633219*PED	2030-10-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	10039718	2032-10-06		Drug product	2018-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203100-001	10039718*PED	2033-04-06		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	7176220	2026-08-27	U-257	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	7635704	2026-10-26	U-257	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8981103	2026-10-26		Drug substance, Drug product	2015-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	7176220*PED	2027-02-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	7635704*PED	2027-04-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8981103*PED	2027-04-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8148374	2029-09-03	U-1279	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	9891239	2029-09-03	U-257	Drug product	2018-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8148374*PED	2030-03-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	9891239*PED	2030-03-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8633219	2030-04-30	U-257	Drug product	2014-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	8633219*PED	2030-10-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	10039718	2032-10-06		Drug product	2018-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203100-001	10039718*PED	2033-04-06		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203100-001	7176220	2026-08-27	U-257	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	7635704	2026-10-26	U-257	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8981103	2026-10-26		Drug substance, Drug product	2015-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	7176220*PED	2027-02-27		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	7635704*PED	2027-04-26		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8981103*PED	2027-04-26		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8148374	2029-09-03	U-1279	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	9891239	2029-09-03	U-257	Drug product	2018-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8148374*PED	2030-03-03		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	9891239*PED	2030-03-03		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8633219	2030-04-30	U-257	Drug product	2014-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203100-001	8633219*PED	2030-10-30		Pediatric extension		`6a471c1ec25d…`

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	N203100-001	NPP	2020-01-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N203100-001	NPP	2020-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203100-001	NPP	2020-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203100-001	NPP	2020-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203100-001	NPP	2020-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203100-001	NPP	2020-01-27	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
81157882-d7f5-4b49-9a52-b2a0c7e54020	Product name	2	20260107
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
233e3f87-da6c-4b7d-80cb-963ca3258270	Product name	2	20240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4	Product name	3	20240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
9c956088-4d4f-4a6e-847e-6f64b96f97f1	Product name	1	20150402
8abcd50f-6149-4309-942e-836623ca381d	Product name	1	20150401
248d7995-abf1-4569-b3c6-f9ebc230e8ef	Product name	1	20150323
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-1201-1	2020-01-31	C162847	48780-1	9d75b9d0-daa7-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD ® (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-1201-1	Stribild	1 in 1 DOSE PACK	TABLET, FILM COATED	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-1201	STRIBILD (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20170412_8ac4d501-7f05-426e-93be-a42240087b0c.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
Stribild	ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc.	74ae2a93-b267-444c-8f0f-a2a6522260ee	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203100 application number: NDA203100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4GDQ854U53	ELVITEGRAVIR	697761-98-1	ELVITEGRAVIR
LW2E03M5PG	COBICISTAT	1004316-88-4	COBICISTAT
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1306292	elvitegravir 150 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	8ac4d501-7f05-426e-93be-a42240087b0c	1
1306298	Stribild 150 MG / 150 MG / 200 MG / 300 MG Oral Tablet	PSN	8ac4d501-7f05-426e-93be-a42240087b0c	1
1306298	cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Stribild]	SBD	8ac4d501-7f05-426e-93be-a42240087b0c	1
1306292	cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	8ac4d501-7f05-426e-93be-a42240087b0c	1
1306292	cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	8ac4d501-7f05-426e-93be-a42240087b0c	1
1306298	Stribild (cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet	SY	8ac4d501-7f05-426e-93be-a42240087b0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-1201-1	69189120101	1 in 1 DOSE PACK	Historical