Triumeq

Product NDC
49702-231
11-digit product format
497020231
Labeler code
49702
Product ID
49702-231_4018a8c7-db0d-481e-b50a-a469ba32ec4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate, dolutegravir sodium, lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA205551
Marketing category
NDA
Marketing start
2014-08-22
Substance
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Active strength
600; 50; 300 mg/1; mg/1; mg/1
Pharmacologic classes
Cytochrome P450 1A1 Inhibitors [MoA], HIV Integrase Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABACAVIR SULFATE600 mg/1
DOLUTEGRAVIR SODIUM50 mg/1
LAMIVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ220T4J9Q2, 1Q1V9V5WYQ, 2T8Q726O95
Rxcui1546888, 1546894, 2598348, 2598352

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8eProduct name820250626
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
3832141c-c294-474a-9473-1052c891450eProduct name220230105
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68Product name320190627
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
44633898-5724-4273-abcc-3541a1107946Product name120180124
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325
7d3f81af-5024-0cff-2664-d433b7688444Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-231-13Triumeq30 in 1 BOTTLETABLET, FILM COATED3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-231-13EA - Each49702-231354f8882-0116-4e18-8f1c-946da77cbd6512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
DOLUTEGRAVIR SODIUMACTIVE INGREDIENT1Q1V9V5WYQTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
ABACAVIRACTIVE MOIETYWR2TIP26VSTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
DOLUTEGRAVIRACTIVE MOIETYDKO1W9H7M1TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
LAMIVUDINEACTIVE MOIETY2T8Q726O95TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
TALCINACTIVE INGREDIENT7SEV7J4R1UTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-231TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED TRIUMEQ PD (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) KIT [VIIV HEALTHCARE COMPANY]27Current NDC, Legacy NDC, 1 package rows20240711_2997739a-aa91-42aa-a206-a70e2db7b84f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2598348abacavir 60 MG / dolutegravir 5 MG / lamiVUDine 30 MG Tablet for Oral SuspensionPSN2997739a-aa91-42aa-a206-a70e2db7b84f30
1546888abacavir 600 MG / dolutegravir 50 MG / lamiVUDine 300 MG Oral TabletPSN2997739a-aa91-42aa-a206-a70e2db7b84f30
1546894Triumeq 600 MG / 50 MG / 300 MG Oral TabletPSN2997739a-aa91-42aa-a206-a70e2db7b84f30
2598352Triumeq PD 60 MG / 5 MG / 30 MG Tablet for Oral SuspensionPSN2997739a-aa91-42aa-a206-a70e2db7b84f30
2598352abacavir 60 MG / dolutegravir 5 MG / lamivudine 30 MG Tablet for Oral Suspension [Triumeq]SBD2997739a-aa91-42aa-a206-a70e2db7b84f30
1546894abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral Tablet [Triumeq]SBD2997739a-aa91-42aa-a206-a70e2db7b84f30
2598348abacavir 60 MG / dolutegravir 5 MG / lamivudine 30 MG Tablet for Oral SuspensionSCD2997739a-aa91-42aa-a206-a70e2db7b84f30
1546888abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG Oral TabletSCD2997739a-aa91-42aa-a206-a70e2db7b84f30
2598348abacavir 60 MG (as abacavir sulfate 70.2 MG) / dolutegravir 5 MG (as dolutegravir sodium 5.26 MG) / lamivudine 30 MG Tablet for Oral SuspensionSY2997739a-aa91-42aa-a206-a70e2db7b84f30
2598352abacavir 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]SY2997739a-aa91-42aa-a206-a70e2db7b84f30
2598348abacavir 60 MG / dolutegravir 5 MG / 3TC 30 MG Tablet for Oral SuspensionSY2997739a-aa91-42aa-a206-a70e2db7b84f30
2598352abacavir 60 MG / dolutegravir 5 MG / 3TC 30 MG Tablet for Oral Suspension [Triumeq]SY2997739a-aa91-42aa-a206-a70e2db7b84f30
1546888abacavir 600 MG / dolutegravir 50 MG / 3TC 300 MG Oral TabletSY2997739a-aa91-42aa-a206-a70e2db7b84f30
1546894abacavir 600 MG / dolutegravir 50 MG / 3TC 300 MG Oral Tablet [Triumeq]SY2997739a-aa91-42aa-a206-a70e2db7b84f30
1546894Triumeq (abacavir 600 MG / dolutegravir 50 MG / lamivudine 300 MG) Oral TabletSY2997739a-aa91-42aa-a206-a70e2db7b84f30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-231-134970202311330 TABLET, FILM COATED in 1 BOTTLE (49702-231-13) 2014-08-220000-00-00NoNoCurrent