ISENTRESS

Product NDC: 68071-2113
11-digit product format: 680712113
Labeler code: 68071
Product ID: 68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RALTEGRAVIR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: NDA022145
Marketing category: NDA
Marketing start: 2007-10-12
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: 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 · 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		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 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 17 · 674 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	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…`
2025-08-23 18:47 UTC	2025-08	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`fd3edfee7708…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ISENTRESS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RALTEGRAVIR POTASSIUM	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43Y000U234	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
744842	Internal RxNorm lookup
744846	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
46ef8e2e-ae63-6a3c-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
323837e1-94ea-4944-ae44-aa6cc9ccda3b	Product name	2	20260223
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2021-02-23	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 ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
2021-02-23	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 ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
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 ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
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 ® (raltegravir) chewable tablets, for oral use ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2113-6	ISENTRESS	6 in 1 BOTTLE	TABLET, FILM COATED	6		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68071-2113-6	EA - Each	68071-2113	f5ab7d03-0c94-4481-b596-5b66ea6818e8	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2113	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240719_46ef8e2e-ae63-6a3c-e054-00144ff8d46c.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 · 4 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 ndc (product): 68071-2113
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
ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	7e659505-c902-4906-9461-1cc83e2236d2	2023-12-09	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
744846	Isentress 400 MG Oral Tablet	PSN	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744842	raltegravir 400 MG Oral Tablet	PSN	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744846	raltegravir 400 MG Oral Tablet [Isentress]	SBD	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744842	raltegravir 400 MG Oral Tablet	SCD	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744846	ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744846	ISENTRESS 400 MG Oral Tablet	SY	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7
744842	raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2113-6	68071211306	6 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)	2017-01-25	0000-00-00	No	No	Current