FDA.reportPublic FDA data

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

Additional Listing Data#

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

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
49702-258-37Triumeq PD1 in 1 CARTONKIT130
49702-272-59Triumeq PD90 in 1 BOTTLETABLET, FILM COATED9030 mg30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-258-37EA - Each49702-258b69bfea5-1ffd-47b8-bbe8-1d1fbc59811a12022-05-04

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
49702-258TRIUMEQ (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) TABLET, FILM COATED TRIUMEQ PD (ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE) KIT [VIIV HEALTHCARE COMPANY]27Current NDC, Legacy NDC, 2 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49702-258-37497020258371 KIT in 1 CARTON (49702-258-37) * 90 TABLET, FILM COATED in 1 BOTTLE (49702-272-59) 1 kit2022-03-300000-00-00NoNoCurrent
49702-272-594970202725990 in 1 BOTTLEHistorical