ISENTRESS

Product NDC: 0006-0477
11-digit product format: 000060477
Labeler code: 0006
Product ID: 0006-0477_70b9b593-db43-43ad-8808-a1c86c048145
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RALTEGRAVIR
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA203045
Marketing category: NDA
Marketing start: 2011-12-21
Substance: RALTEGRAVIR POTASSIUM
Active strength: 100 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
N203045-001	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 25MG BASE	TABLET, CHEWABLE / ORAL		RLD	2011-12-21
N203045-002	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 100MG BASE	TABLET, CHEWABLE / ORAL		RLD, RS	2011-12-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20
N203045-001	7754731*PED	2029-09-11		Pediatric extension
N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product
N203045-002	7754731*PED	2029-09-11		Pediatric extension
N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 473 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	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203045-001	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-001	PED	2021-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-002	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-002	PED	2021-05-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N203045-001	PED	2021-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203045-002	PED	2021-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203045-001	PED	2021-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203045-002	PED	2021-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203045-001	PED	2021-05-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203045-002	PED	2021-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203045-001	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-001	PED	2021-05-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-002	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-002	PED	2021-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203045-001	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-001	PED	2021-05-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-002	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-002	PED	2021-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203045-001	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-001	PED	2021-05-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-002	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-002	PED	2021-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203045-001	NPP	2020-11-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-001	PED	2021-05-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-002	NPP	2020-11-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-002	PED	2021-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203045-001	NPP	2020-11-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-001	PED	2021-05-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-002	NPP	2020-11-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-002	PED	2021-05-22	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RALTEGRAVIR POTASSIUM	100 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
744842	Internal RxNorm lookup
744846	Internal RxNorm lookup
1235588	Internal RxNorm lookup
1235591	Internal RxNorm lookup
1235593	Internal RxNorm lookup
1235595	Internal RxNorm lookup
1486838	Internal RxNorm lookup
1486841	Internal RxNorm lookup
1924313	Internal RxNorm lookup
1924315	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
89a5ec53-d956-4329-8004-0f40f51c88a3	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-0477-61	ISENTRESS	60 in 1 BOTTLE	TABLET, CHEWABLE	60		70

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0477-61	EA - Each	0006-0477	1feeedfb-904c-43d6-84a6-de27a293a883	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RALTEGRAVIR POTASSIUM	ACTIVE INGREDIENT	43Y000U234	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
RALTEGRAVIR	ACTIVE MOIETY	22VKV8053U	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
ETHYLCELLULOSE (20 MPA.S)	INACTIVE INGREDIENT	BJG0S321QY	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
FRUCTOSE	INACTIVE INGREDIENT	6YSS42VSEV	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]	49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-0477	ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]	69	Current NDC, Legacy NDC, 1 package rows	20241030_89a5ec53-d956-4329-8004-0f40f51c88a3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	89a5ec53-d956-4329-8004-0f40f51c88a3	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203045 application number: NDA203045 ndc (product): 0006-0477

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
1235591	Isentress 100 MG Chewable Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486841	Isentress 100 MG Granules for Oral Suspension	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235595	Isentress 25 MG Chewable Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744846	Isentress 400 MG Oral Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924315	Isentress 600 MG Oral Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235588	raltegravir 100 MG Chewable Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486838	raltegravir 100 MG Granules for Oral Suspension	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235593	raltegravir 25 MG Chewable Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744842	raltegravir 400 MG Oral Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924313	raltegravir 600 MG Oral Tablet	PSN	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235591	raltegravir 100 MG Chewable Tablet [Isentress]	SBD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486841	raltegravir 100 MG Granules for Oral Suspension [Isentress]	SBD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235595	raltegravir 25 MG Chewable Tablet [Isentress]	SBD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744846	raltegravir 400 MG Oral Tablet [Isentress]	SBD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924315	raltegravir 600 MG Oral Tablet [Isentress]	SBD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235588	raltegravir 100 MG Chewable Tablet	SCD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486838	raltegravir 100 MG Granules for Oral Suspension	SCD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235593	raltegravir 25 MG Chewable Tablet	SCD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744842	raltegravir 400 MG Oral Tablet	SCD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924313	raltegravir 600 MG Oral Tablet	SCD	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486841	Isentress (raltegravir 100 MG (as raltegravir potassium 108.8 MG)) Granules for Oral Suspension	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235591	ISENTRESS 100 MG (raltegravir potassium 108.6 MG) Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235591	ISENTRESS 100 MG Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486841	Isentress 100 MG Granules for Oral Suspension	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235595	ISENTRESS 25 MG (raltegravir potassium 27.16 MG) Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235595	ISENTRESS 25 MG Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744846	ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744846	ISENTRESS 400 MG Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924315	Isentress 600 MG (as raltegravir potassium 651.6 MG) Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924315	Isentress 600 MG Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235588	raltegravir (as raltegravir potassium) 100 MG Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1235593	raltegravir (as raltegravir potassium) 25 MG Chewable Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1486838	raltegravir 100 MG (as raltegravir potassium 108.8 MG) Granules for Oral Suspension	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
744842	raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70
1924313	raltegravir 600 MG (as raltegravir potassium 651.6 MG) Oral Tablet	SY	89a5ec53-d956-4329-8004-0f40f51c88a3	70

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0477-61	00006047761	60 TABLET, CHEWABLE in 1 BOTTLE (0006-0477-61)	2011-12-21	0000-00-00	No	No	Current