Home NDC 50090-1606 Triumeq
Product NDC 50090-1606
11-digit product format 500901606
Labeler code 50090
Product ID 50090-1606_37a43c59-6382-40e8-9a5b-cc9d0e01122d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate, dolutegravir sodium, lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA205551
Marketing category NDA
Marketing start 2014-08-22
Marketing end 0000-00-00
Substance ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Active strength 600 mg/1; mg/1; mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1606-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1606-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1606-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1606-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1606-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1606-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1606-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1606-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1606-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1606-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-1606-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-1606-0 557ba5c1ecfa…9c80585c8c6e…
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 N205551-001 TRIUMEQ ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 N205551-001 8129385*PED 2028-04-05 Pediatric extension N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 N205551-001 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 N205551-001 M-294 2026-06-15 N205551-001 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.
Product history page 1 of 2 · 41 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 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205551-001 TRIUMEQ EQ 600MG BASE;EQ 50MG BASE;300MG TABLET / ORAL RLD, RS 2014-08-22 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 4 · 124 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 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 8129385*PED 2028-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205551-001 9242986*PED 2030-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 8129385*PED 2028-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205551-001 9242986*PED 2030-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 8129385*PED 2028-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205551-001 9242986*PED 2030-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 8129385*PED 2028-04-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205551-001 9242986*PED 2030-06-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 8129385*PED 2028-04-05 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205551-001 9242986*PED 2030-06-08 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 8129385*PED 2028-04-05 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205551-001 9242986*PED 2030-06-08 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 8129385*PED 2028-04-05 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205551-001 9242986*PED 2030-06-08 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 8129385*PED 2028-04-05 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205551-001 9242986*PED 2030-06-08 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 8129385*PED 2028-04-05 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205551-001 9242986*PED 2030-06-08 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205551-001 8129385 2027-10-05 Drug substance, Drug product 2014-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205551-001 8129385*PED 2028-04-05 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205551-001 9242986 2029-12-08 Drug substance, Drug product 2016-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205551-001 9242986*PED 2030-06-08 Pediatric extension d06236e962d9…
Observed Orange Book exclusivity history# 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): 205551 application number: NDA205551