Tivicay

Product NDC
60760-748
11-digit product format
607600748
Labeler code
60760
Product ID
60760-748_526982bc-f7b7-0c37-e063-6394a90a6d6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOLUTEGRAVIR SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Q1V9V5WYQ
Rxcui1433873, 1433879

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
60760-748-07Tivicay7 in 1 BOTTLE, PLASTICTABLET, FILM COATED72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-748-07EA - Each60760-7481517501d-647f-4a4f-b654-383f3d2f687612026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433873dolutegravir 50 MG Oral TabletPSN485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG Oral TabletPSN485bc9db-8665-9f5a-e063-6394a90a79212
1433879dolutegravir 50 MG Oral Tablet [Tivicay]SBD485bc9db-8665-9f5a-e063-6394a90a79212
1433873dolutegravir 50 MG Oral TabletSCD485bc9db-8665-9f5a-e063-6394a90a79212
1433873dolutegravir 50 MG (as dolutegravir sodium 52.6 MG) Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG (as dolutegravir sodium) Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212
1433879Tivicay 50 MG Oral TabletSY485bc9db-8665-9f5a-e063-6394a90a79212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-748-07607600748077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07) 2026-01-16NoNoHistorical