ISENTRESS

Product NDC: 61919-706
Requested package NDC: 61919-706-06
11-digit product format: 619190706
Labeler code: 61919
Product ID: 61919-706_d5e239df-4a66-354f-e053-2995a90a1a57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ISENTRESS
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: NDA022145
Marketing category: NDA
Marketing start: 2016-12-21
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-706	61919-706-06	I	Inactivated by FDA		2026-08-10

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-706-02	2025-01-30	2cef2736-5df6-d83d-e063-dadaa90ab31f	ISENTRESS
61919-706-04	2025-01-30	9d75b9d0-192a-f424-e053-dadaa90a57ce	ISENTRESS
61919-706-06	2025-01-30	9d75b9d0-192a-f424-e053-dadaa90a57ce	ISENTRESS
61919-706-04	2021-01-12	9d75b9d0-192a-f424-e053-dadaa90a57ce	ISENTRESS
61919-706-04	2020-01-31	9d75b9d0-192a-f424-e053-dadaa90a57ce	ISENTRESS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-706-02	ISENTRESS	2 in 1 BOTTLE	TABLET, FILM COATED	2	3
61919-706-04	ISENTRESS	4 in 1 BOTTLE	TABLET, FILM COATED	4	3
61919-706-06	ISENTRESS	6 in 1 BOTTLE	TABLET, FILM COATED	6	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-706-02	EA - Each	61919-706	8756dbff-4c22-4ef2-b9e9-b68ea85e4c98	1	2019-09-05
61919-706-06	EA - Each	61919-706	ca624b2c-cd0b-4168-ba61-e91d2aaf13cb	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-706	ISENTRESS TABLET, FILM COATED [DIRECT RX]	3	Legacy NDC, 2 package rows	20220119_442d9e67-1c2c-73f8-e054-00144ff8d46c.zip
61919-706	ISENTRESS TABLET, FILM COATED [DIRECT_RX]	3	Legacy NDC, 1 package rows	20210113_9000a7ea-efce-3fba-e053-2a95a90ae2c3.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
744842	raltegravir 400 MG Oral Tablet	PSN	442d9e67-1c2c-73f8-e054-00144ff8d46c	3
744842	raltegravir 400 MG Oral Tablet	PSN	9000a7ea-efce-3fba-e053-2a95a90ae2c3	3
744842	raltegravir 400 MG Oral Tablet	SCD	442d9e67-1c2c-73f8-e054-00144ff8d46c	3
744842	raltegravir 400 MG Oral Tablet	SCD	9000a7ea-efce-3fba-e053-2a95a90ae2c3	3
744842	raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	442d9e67-1c2c-73f8-e054-00144ff8d46c	3
744842	raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	9000a7ea-efce-3fba-e053-2a95a90ae2c3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-706-06	61919070606	6 TABLET, FILM COATED in 1 BOTTLE (61919-706-06)	2016-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISENTRESS	DIRECT RX	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
ISENTRESS	Direct_Rx	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	3