FDA.reportPublic FDA data

Tivicay

Product NDC
49702-228
11-digit product format
497020228
Labeler code
49702
Product ID
49702-228_a9175b83-2200-4bd2-9ee3-52095b5d2657
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA204790
Marketing category
NDA
Marketing start
2013-08-13
Substance
DOLUTEGRAVIR SODIUM
Active strength
50 mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOLUTEGRAVIR SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Q1V9V5WYQ
Rxcui1433873, 1433879, 1796077, 1796079, 1796081, 1796083, 2374562, 2374566

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3832141c-c294-474a-9473-1052c891450eProduct name220230105
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
44633898-5724-4273-abcc-3541a1107946Product name120180124
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
49702-228-13Tivicay30 in 1 BOTTLETABLET, FILM COATED3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-228-13EA - Each49702-228a0c068b2-5b99-451c-82ca-f1fc15dcc6b612013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOLUTEGRAVIR SODIUMACTIVE INGREDIENT1Q1V9V5WYQTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
DOLUTEGRAVIRACTIVE MOIETYDKO1W9H7M1TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
MANNITOLINACTIVE INGREDIENT3OWL53L36ATIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ETIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
TALCINACTIVE INGREDIENT7SEV7J4R1UTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-228TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]29Current NDC, Legacy NDC, 1 package rows20240907_63df5af3-b8ac-4e76-9830-2dbb340af922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1796077dolutegravir 10 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1796081dolutegravir 25 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
2374562dolutegravir 5 MG Tablet for Oral SuspensionPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1433873dolutegravir 50 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1796079Tivicay 10 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1796083Tivicay 25 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1433879Tivicay 50 MG Oral TabletPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
2374566Tivicay PD 5 MG Tablet for Oral SuspensionPSN63df5af3-b8ac-4e76-9830-2dbb340af92231
1796079dolutegravir 10 MG Oral Tablet [Tivicay]SBD63df5af3-b8ac-4e76-9830-2dbb340af92231
1796083dolutegravir 25 MG Oral Tablet [Tivicay]SBD63df5af3-b8ac-4e76-9830-2dbb340af92231
2374566dolutegravir 5 MG Tablet for Oral Suspension [Tivicay]SBD63df5af3-b8ac-4e76-9830-2dbb340af92231
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBD63df5af3-b8ac-4e76-9830-2dbb340af92231
1796077dolutegravir 10 MG Oral TabletSCD63df5af3-b8ac-4e76-9830-2dbb340af92231
1796081dolutegravir 25 MG Oral TabletSCD63df5af3-b8ac-4e76-9830-2dbb340af92231
2374562dolutegravir 5 MG Tablet for Oral SuspensionSCD63df5af3-b8ac-4e76-9830-2dbb340af92231
1433873dolutegravir 50 MG Oral TabletSCD63df5af3-b8ac-4e76-9830-2dbb340af92231
1796077dolutegravir 10 MG (as dolutegravir sodium) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1796081dolutegravir 25 MG (as dolutegravir sodium) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
2374562dolutegravir 5 MG (as dolutegravir sodium) Tablet for Oral SuspensionSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1796079Tivicay 10 MG (as dolutegravir sodium) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1796083Tivicay 25 MG (as dolutegravir sodium) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1433879Tivicay 50 MG Oral TabletSY63df5af3-b8ac-4e76-9830-2dbb340af92231
2374566Tivicay PD 5 MG (as dolutegravir sodium) Tablet for Oral SuspensionSY63df5af3-b8ac-4e76-9830-2dbb340af92231
2374566Tivicay PD 5 MG Tablet for Oral SuspensionSY63df5af3-b8ac-4e76-9830-2dbb340af92231
1433873dolutegravir 50 MG Oral TabletPSNb00132b8-58b1-7533-e053-2995a90a0cf15
1433879Tivicay 50 MG Oral TabletPSNb00132b8-58b1-7533-e053-2995a90a0cf15
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBDb00132b8-58b1-7533-e053-2995a90a0cf15
1433873dolutegravir 50 MG Oral TabletSCDb00132b8-58b1-7533-e053-2995a90a0cf15
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSYb00132b8-58b1-7533-e053-2995a90a0cf15
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSYb00132b8-58b1-7533-e053-2995a90a0cf15
1433879Tivicay 50 MG Oral TabletSYb00132b8-58b1-7533-e053-2995a90a0cf15
1433873dolutegravir 50 MG Oral TabletPSN485bc9db-8665-9f5a-e063-6394a90a79212
1433873dolutegravir 50 MG Oral TabletPSN44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433879Tivicay 50 MG Oral TabletPSN485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG Oral TabletPSN44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBD485bc9db-8665-9f5a-e063-6394a90a79212
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBD44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433873dolutegravir 50 MG Oral TabletSCD485bc9db-8665-9f5a-e063-6394a90a79212
1433873dolutegravir 50 MG Oral TabletSCD44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSY44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSY44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433879Tivicay 50 MG Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG Oral TabletSY44c4bbcc-fe93-4b4b-ad6a-12f46d2354ec2
1433873dolutegravir 50 MG Oral TabletPSN807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433879Tivicay 50 MG Oral TabletPSN807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBD807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433873dolutegravir 50 MG Oral TabletSCD807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSY807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSY807b0cd2-093c-4353-a4a5-2e1f264616ba1
1433879Tivicay 50 MG Oral TabletSY807b0cd2-093c-4353-a4a5-2e1f264616ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-228-134970202281330 TABLET, FILM COATED in 1 BOTTLE (49702-228-13) 2013-08-130000-00-00NoNoCurrent