ISENTRESS

Product NDC: 70518-1621
11-digit product format: 705181621
Labeler code: 70518
Product ID: 70518-1621_d9b8c0ba-9b03-6518-e053-2995a90ada6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RALTEGRAVIR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA022145
Marketing category: NDA
Marketing start: 2018-10-31
Marketing end: 0000-00-00
Substance: RALTEGRAVIR POTASSIUM
Active strength: 400 mg/1
Pharmacologic classes: HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1621		D	Discontinued by firm	2026-10-02
excluded package	package	70518-1621	70518-1621-0	D	Discontinued by firm	2026-10-02
excluded package	package	70518-1621	70518-1621-1	D	Discontinued by firm	2026-10-02
excluded package	package	70518-1621	70518-1621-2	D	Discontinued by firm	2026-10-02

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 · 32 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	70518-1621-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1621-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1621-1	`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	70518-1621-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1621-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1621-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	70518-1621-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1621-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1621-0	`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	70518-1621-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1621-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1621-0	`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	70518-1621-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1621-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1621-0	`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	70518-1621-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1621-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1621-0	`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	70518-1621-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1621-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1621-0	`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	70518-1621-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1621-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1621-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022145-001	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12
N022145-002	ISENTRESS HD	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022145-001	AB
N022145-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27
N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product
N022145-001	7754731*PED	2029-09-11		Pediatric extension
N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23
N022145-002	7754731*PED	2029-09-11		Pediatric extension
N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	9649311	2030-10-21		Drug product	2017-06-23
N022145-002	9649311*PED	2031-04-21		Pediatric extension
N022145-002	10772888	2032-03-30	U-1663		2020-10-27

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022145-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-002	AB	1	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022145-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 694 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022145-001	D-167	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2021-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NS	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2021-05-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022145-001	PED	2021-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022145-002	PED	2021-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-001	PED	2021-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-002	PED	2021-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022145-001	PED	2021-05-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022145-002	PED	2021-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022145-001	D-167	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2021-05-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NS	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2021-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022145-001	D-167	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2021-05-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NS	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2021-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022145-001	D-167	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2021-05-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NS	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2021-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022145-001	D-167	2020-05-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022145-001	NPP	2020-11-22	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-1621-0	2021-06-01	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
70518-1621-1	2021-06-01	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
70518-1621-2	2021-06-01	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
70518-1621-0	2021-01-29	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
70518-1621-1	2021-01-29	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
70518-1621-2	2021-01-29	These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) film-coated tablets, for oral use ISENTRESS ® HD (raltegravir) film-coated tablets, for oral use ISENTRESS ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1621	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [REMEDYREPACK INC.]	8	Legacy NDC	20250226_cf9085f0-7353-40e1-bc40-0295ace92aab.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022145 application number: NDA022145
ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	89a5ec53-d956-4329-8004-0f40f51c88a3	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022145 application number: NDA022145
ISENTRESS	RALTEGRAVIR	Proficient Rx LP	ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022145 application number: NDA022145

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43Y000U234	RALTEGRAVIR POTASSIUM	871038-72-1	RALTEGRAVIR POTASSIUM
22VKV8053U	RALTEGRAVIR	518048-05-0	RALTEGRAVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1621-0	70518162100	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-0)	2018-10-31	0000-00-00	No	No	Current
70518-1621-1	70518162101	6 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-1)	2019-01-17	0000-00-00	No	No	Current
70518-1621-2	70518162102	8 TABLET, FILM COATED in 1 BLISTER PACK (70518-1621-2)	2019-01-17	0000-00-00	No	No	Current