Intelence

Product NDC: 59676-571
Requested package NDC: 59676-571-01
11-digit product format: 596760571
Labeler code: 59676
Product ID: 59676-571_02fc6f4f-330d-b32e-e063-6294a90a028a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etravirine
Dosage form: TABLET
Route: ORAL
Labeler: Janssen Products LP
Application: NDA022187
Marketing category: NDA
Marketing start: 2010-12-22
Substance: ETRAVIRINE
Active strength: 200 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022187-001	INTELENCE	ETRAVIRINE	100MG	TABLET / ORAL	AB	RLD	2008-01-18
N022187-002	INTELENCE	ETRAVIRINE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22
N022187-003	INTELENCE	ETRAVIRINE	25MG	TABLET / ORAL		RLD	2012-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022187-001	AB
N022187-002	AB

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 4 · 123 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	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022187-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022187-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022187-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022187-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022187-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022187-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022187-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022187-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 207 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022187-001	7887845	2019-03-25		Drug product	2011-03-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	8003789	2019-11-01		Drug substance, Drug product	2011-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-1016			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-256			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-2354			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-1237			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-1016	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-256	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-1237	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-2354	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7887845	2019-03-25		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	8003789	2019-11-01		Drug substance, Drug product	2011-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-1016		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-2354		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-256		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-1237		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-2354	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-256	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-1016	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-1237	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7887845	2019-03-25		Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	8003789	2019-11-01		Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-2354		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-256		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-1016		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-1237		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917	2020-12-13	U-2354	Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917	2020-12-13	U-1237	Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-001	PED	2022-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-002	PED	2022-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-003	PED	2022-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022187-001	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-002	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-003	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022187-001	PED	2022-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-002	PED	2022-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-003	PED	2022-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022187-001	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	PED	2022-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	PED	2022-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	PED	2022-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022187-001	PED	2022-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-002	PED	2022-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-003	PED	2022-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022187-001	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-001	PED	2022-01-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-002	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-002	PED	2022-01-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-003	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-003	PED	2022-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-001	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-001	PED	2022-01-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-002	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-002	PED	2022-01-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-003	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-003	PED	2022-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022187-001	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-001	PED	2022-01-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-002	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-002	PED	2022-01-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-003	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-003	PED	2022-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022187-001	NPP	2021-07-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-001	PED	2022-01-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-002	NPP	2021-07-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-002	PED	2022-01-16	`8869cabd3fbd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Intelence
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETRAVIRINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0C50HW4FO1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
754761	Internal RxNorm lookup
758555	Internal RxNorm lookup
1052658	Internal RxNorm lookup
1052660	Internal RxNorm lookup
1250721	Internal RxNorm lookup
1250723	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6a9cbc29-9f15-4b24-8d86-206b82887f3d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
08bcdf9c-0f44-79ee-51ca-e7f77478ea2e	Product name	2	20230112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59676-571-01	Intelence	60 in 1 BOTTLE, PLASTIC	TABLET	60		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-571-01	EA - Each	59676-571	c08dae44-333e-4bfb-b0db-efe76c9580ea	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
etravirine	ACTIVE INGREDIENT	0C50HW4FO1	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
etravirine	ACTIVE MOIETY	0C50HW4FO1	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	13
etravirine	ACTIVE INGREDIENT	0C50HW4FO1	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
etravirine	ACTIVE MOIETY	0C50HW4FO1	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	INTELENCE (ETRAVIRINE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-571	INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]	24	Current NDC, Legacy NDC, 1 package rows	20230816_6a9cbc29-9f15-4b24-8d86-206b82887f3d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etravirine	ETRAVIRINE	Patriot Pharmaceuticals	50ca19cb-0f43-4d7b-8c9e-8b3aaded0546	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022187 application number: NDA022187
Intelence	ETRAVIRINE	Janssen Products LP	6a9cbc29-9f15-4b24-8d86-206b82887f3d	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022187 application number: NDA022187 ndc (package): 59676-571-01 ndc (product): 59676-571 ndc11 (package): 59676057101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0C50HW4FO1	ETRAVIRINE	269055-15-4	ETRAVIRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
754761	etravirine 100 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1052658	etravirine 200 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1250721	etravirine 25 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
758555	INTELENCE 100 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1052660	INTELENCE 200 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1250723	INTELENCE 25 MG Oral Tablet	PSN	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
758555	etravirine 100 MG Oral Tablet [Intelence]	SBD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1052660	etravirine 200 MG Oral Tablet [Intelence]	SBD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1250723	etravirine 25 MG Oral Tablet [Intelence]	SBD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
754761	etravirine 100 MG Oral Tablet	SCD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1052658	etravirine 200 MG Oral Tablet	SCD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1250721	etravirine 25 MG Oral Tablet	SCD	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
758555	Intelence 100 MG Oral Tablet	SY	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1052660	Intelence 200 MG Oral Tablet	SY	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
1250723	Intelence 25 MG Oral Tablet	SY	6a9cbc29-9f15-4b24-8d86-206b82887f3d	24
754761	etravirine 100 MG Oral Tablet	PSN	73667241-b95a-49b0-9c51-a4289f20d5c2	2
1052658	etravirine 200 MG Oral Tablet	PSN	73667241-b95a-49b0-9c51-a4289f20d5c2	2
758555	INTELENCE 100 MG Oral Tablet	PSN	73667241-b95a-49b0-9c51-a4289f20d5c2	2
1052660	INTELENCE 200 MG Oral Tablet	PSN	73667241-b95a-49b0-9c51-a4289f20d5c2	2
758555	etravirine 100 MG Oral Tablet [Intelence]	SBD	73667241-b95a-49b0-9c51-a4289f20d5c2	2
1052660	etravirine 200 MG Oral Tablet [Intelence]	SBD	73667241-b95a-49b0-9c51-a4289f20d5c2	2
754761	etravirine 100 MG Oral Tablet	SCD	73667241-b95a-49b0-9c51-a4289f20d5c2	2
1052658	etravirine 200 MG Oral Tablet	SCD	73667241-b95a-49b0-9c51-a4289f20d5c2	2
758555	Intelence 100 MG Oral Tablet	SY	73667241-b95a-49b0-9c51-a4289f20d5c2	2
1052660	Intelence 200 MG Oral Tablet	SY	73667241-b95a-49b0-9c51-a4289f20d5c2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59676-571-01	59676057101	60 TABLET in 1 BOTTLE, PLASTIC (59676-571-01)	60 tablet	2010-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Intelence	Janssen Products LP \| Janssen Pharmaceutica NV \| Janssen Cilag SpA \| Johnson and Johnson Private Limited \| Janssen Pharmaceuticals, Inc \| JANSSEN ORTHO LLC	2023-08-15	HUMAN PRESCRIPTION DRUG LABEL	24
Intelence	Physicians Total Care, Inc.	2013-01-02	HUMAN PRESCRIPTION DRUG LABEL	2