FDA.reportPublic FDA data

Tivicay PD

Product NDC
49702-255
11-digit product format
497020255
Labeler code
49702
Product ID
49702-255_a9175b83-2200-4bd2-9ee3-52095b5d2657
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA213983
Marketing category
NDA
Marketing start
2020-06-12
Substance
DOLUTEGRAVIR SODIUM
Active strength
5 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 PD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOLUTEGRAVIR SODIUM5 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
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
44633898-5724-4273-abcc-3541a1107946Product name120180124
7d3f81af-5024-0cff-2664-d433b7688444Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-255-37Tivicay PD60 in 1 BOTTLETABLET, FOR SUSPENSION6031
49702-255-37Tivicay PD1 in 1 CARTONTABLET, FOR SUSPENSION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-255-37EA - Each49702-255fbbbc9ca-1048-4228-999d-225e0ab6fb8212020-07-13

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
49702-255TIVICAY PD (DOLUTEGRAVIR SODIUM) TABLET, FOR SUSPENSION TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]29Current NDC, Legacy NDC, 2 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49702-255-37497020255371 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE1 bottle2020-06-120000-00-00NoNoCurrent