Atripla

Product NDC: 53808-0208
11-digit product format: 538080208
Labeler code: 53808
Product ID: 53808-0208_20fe8a0b-95db-4d4c-80e2-54a9126ab845
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: NDA021937
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 600 mg/1; mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 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: No
Listing certified through: 2019-12-31
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	53808-0208		I	Inactivated by FDA		2026-08-11
excluded package	package	53808-0208	53808-0208-1	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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0208-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0208-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0208-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0208-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0208-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0208-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0208-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0208-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0208-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0208-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0208-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0208-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0208-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0208-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0208-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0208-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0208-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0208-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0208-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0208-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0208-1	`9bebd1f3094a…`	`5416666fcb17…`

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
N021937-001	ATRIPLA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-07-12

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021937-001	9018192	2026-06-13	U-1170		2015-05-28
N021937-001	9018192	2026-06-13	U-750		2015-05-28
N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13
N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13
N021937-001	8598185	2029-04-28		Drug product

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021937-001	ATRIPLA	600MG;200MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL		RLD	2006-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021937-001	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021937-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021937-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021937-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021937-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021937-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021937-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021937-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021937-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021937-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021937-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021937-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021937-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021937-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021937-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021937-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021937-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021937-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021937-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021937-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021937-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021937-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021937-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021937-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021937-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021937-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021937-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021937-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021937-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021937-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021937-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 419 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	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	8598185	2029-04-28		Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	8598185	2029-04-28		Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	8598185	2029-04-28		Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	8598185	2029-04-28		Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	8598185	2029-04-28		Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	8592397	2024-01-13	U-1170	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	8592397	2024-01-13	U-750	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021937-001	8598185	2029-04-28		Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	8592397	2024-01-13	U-1170	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	8592397	2024-01-13	U-750	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021937-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
649b204e-4c3b-7f17-657b-ae3f2995e611	Product name	7	20250220
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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0b	Product name	1	20180221
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
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
53808-0208-1	2020-01-31	C162847	48780-1	9d75b9d0-8ec3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA ® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0208-1	Atripla	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EFAVIRENZ	ACTIVE INGREDIENT	JE6H2O27P8	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
EMTRICITABINE	ACTIVE INGREDIENT	G70B4ETF4S	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TENOFOVIR DISOPROXIL FUMARATE	ACTIVE INGREDIENT	OTT9J7900I	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
efavirenz	ACTIVE MOIETY	JE6H2O27P8	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
emtricitabine	ACTIVE MOIETY	G70B4ETF4S	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
Tenofovir	ACTIVE MOIETY	99YXE507IL	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0208	ATRIPLA (EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [DOH CENTRAL PHARMACY]	3	Legacy NDC, 1 package rows	20170203_076da359-b3d0-44f7-8c0e-662f5b7a8668.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE6H2O27P8	EFAVIRENZ	154598-52-4	EFAVIRENZ
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
643070	ATRIPLA 600 MG / 200 MG / 300 MG Oral Tablet	PSN	076da359-b3d0-44f7-8c0e-662f5b7a8668	3
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	076da359-b3d0-44f7-8c0e-662f5b7a8668	3
643070	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Atripla]	SBD	076da359-b3d0-44f7-8c0e-662f5b7a8668	3
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	076da359-b3d0-44f7-8c0e-662f5b7a8668	3
643070	Atripla (efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet	SY	076da359-b3d0-44f7-8c0e-662f5b7a8668	3
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	076da359-b3d0-44f7-8c0e-662f5b7a8668	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0208-1	53808020801	30 in 1 BLISTER PACK	Historical