Triumeq PD

Product NDC: 49702-258
11-digit product format: 497020258
Labeler code: 49702
Product ID: 49702-258_4018a8c7-db0d-481e-b50a-a469ba32ec4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abacavir sulfate, dolutegravir sodium, lamivudine
Dosage form: KIT
Labeler: ViiV Healthcare Company
Application: NDA215413
Marketing category: NDA
Marketing start: 2022-03-30
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215413-001	TRIUMEQ PD	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2022-03-30

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07
N215413-001	8129385*PED	2028-04-05	Pediatric extension
N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07
N215413-001	9242986*PED	2030-06-08	Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215413-001	NPP	2026-06-15
N215413-001	PED	2026-12-15

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.

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	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215413-001	TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2022-03-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215413-001	8129385	2027-10-05	Drug substance, Drug product	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215413-001	8129385*PED	2028-04-05	Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215413-001	9242986	2029-12-08	Drug substance, Drug product	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215413-001	9242986*PED	2030-06-08	Pediatric extension		`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215413-001	NPP	2026-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215413-001	PED	2026-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	NPP	2026-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215413-001	PED	2026-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215413-001	NPP	2026-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215413-001	PED	2026-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	NPP	2026-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215413-001	PED	2026-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	NPP	2026-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215413-001	PED	2026-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	NPP	2026-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215413-001	PED	2026-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	NPP	2026-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215413-001	PED	2026-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	NPP	2026-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215413-001	PED	2026-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	NPP	2026-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215413-001	PED	2026-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215413-001	NPP	2026-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215413-001	PED	2026-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215413-001	NPP	2026-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215413-001	PED	2026-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215413-001	NPP	2026-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215413-001	PED	2026-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215413-001	NPP	2026-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215413-001	PED	2026-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215413-001	NPP	2026-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215413-001	PED	2026-12-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215413-001	NPP	2026-06-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215413-001	PED	2026-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215413-001	NPP	2026-06-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215413-001	PED	2026-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215413-001	NPP	2026-06-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215413-001	PED	2026-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215413-001	NPP	2026-06-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215413-001	PED	2026-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215413-001	NPP	2026-06-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215413-001	PED	2026-12-15	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215413-001	NPP	2026-06-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215413-001	PED	2026-12-15	`a50c72e98297…`

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J220T4J9Q2	Internal UNII lookup
1Q1V9V5WYQ	Internal UNII lookup
2T8Q726O95	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1546888	Internal RxNorm lookup
1546894	Internal RxNorm lookup
2598348	Internal RxNorm lookup
2598352	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
2997739a-aa91-42aa-a206-a70e2db7b84f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aaa99659-c62c-7281-d402-9590409850c2	Product name	6	20260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8e	Product name	8	20250626
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68	Product name	3	20190627
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1	Product name	7	20181210
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862a	Product name	4	20180604
44633898-5724-4273-abcc-3541a1107946	Product name	1	20180124
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325
7d3f81af-5024-0cff-2664-d433b7688444	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49702-258-37	Triumeq PD	1 in 1 CARTON	KIT	1		30
49702-272-59	Triumeq PD	90 in 1 BOTTLE	TABLET, FILM COATED	90	30 mg	30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49702-258-37	EA - Each	49702-258	b69bfea5-1ffd-47b8-bbe8-1d1fbc59811a	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ABACAVIR SULFATE	ACTIVE INGREDIENT	J220T4J9Q2	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
DOLUTEGRAVIR SODIUM	ACTIVE INGREDIENT	1Q1V9V5WYQ	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
LAMIVUDINE	ACTIVE INGREDIENT	2T8Q726O95	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
ABACAVIR	ACTIVE MOIETY	WR2TIP26VS	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
DOLUTEGRAVIR	ACTIVE MOIETY	DKO1W9H7M1	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
LAMIVUDINE	ACTIVE MOIETY	2T8Q726O95	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49702-258	TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED TRIUMEQ PD (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) KIT [VIIV HEALTHCARE COMPANY]	27	Current NDC, Legacy NDC, 2 package rows	20240711_2997739a-aa91-42aa-a206-a70e2db7b84f.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
Triumeq	ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE	ViiV Healthcare Company	2997739a-aa91-42aa-a206-a70e2db7b84f	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215413 application number: NDA215413 ndc (product): 49702-258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2598348	abacavir 60 MG / dolutegravir 5 MG / lamiVUDine 30 MG Tablet for Oral Suspension	PSN	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546888	abacavir 600 MG / dolutegravir 50 MG / lamiVUDine 300 MG Oral Tablet	PSN	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546894	Triumeq 600 MG / 50 MG / 300 MG Oral Tablet	PSN	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598352	Triumeq PD 60 MG / 5 MG / 30 MG Tablet for Oral Suspension	PSN	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598352	abacavir 60 MG / dolutegravir 5 MG / lamivudine 30 MG Tablet for Oral Suspension [Triumeq]	SBD	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546894	abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral Tablet [Triumeq]	SBD	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598348	abacavir 60 MG / dolutegravir 5 MG / lamivudine 30 MG Tablet for Oral Suspension	SCD	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546888	abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral Tablet	SCD	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598348	abacavir 60 MG (as abacavir sulfate 70.2 MG) / dolutegravir 5 MG (as dolutegravir sodium 5.26 MG) / lamivudine 30 MG Tablet for Oral Suspension	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598352	abacavir 60 MG (as abacavir sulfate 70.2 MG) / dolutegravir 5 MG (as dolutegravir sodium 5.26 MG) / lamivudine 30 MG Tablet for Oral Suspension [Triumeq]	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598348	abacavir 60 MG / dolutegravir 5 MG / 3TC 30 MG Tablet for Oral Suspension	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
2598352	abacavir 60 MG / dolutegravir 5 MG / 3TC 30 MG Tablet for Oral Suspension [Triumeq]	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546888	abacavir 600 MG / dolutegravir 50 MG / 3TC 300 MG Oral Tablet	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546894	abacavir 600 MG / dolutegravir 50 MG / 3TC 300 MG Oral Tablet [Triumeq]	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30
1546894	Triumeq (abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG) Oral Tablet	SY	2997739a-aa91-42aa-a206-a70e2db7b84f	30

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49702-258-37	49702025837	1 KIT in 1 CARTON (49702-258-37) * 90 TABLET, FILM COATED in 1 BOTTLE (49702-272-59)	1 kit	2022-03-30	0000-00-00	No	No	Current
49702-272-59	49702027259	90 in 1 BOTTLE						Historical