FDA.reportPublic FDA data

Tivicay

Product NDC
53808-1130
11-digit product format
538081130
Labeler code
53808
Product ID
53808-1130_51db3b9b-9a78-4c16-ad8e-b72fedd6a581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dolutegravir sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
NDA204790
Marketing category
NDA
Marketing start
2017-07-10
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1130-12024-01-30C16284748780-11030e365-6c40-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY. TIVICAY (dolutegravir tablets), for oral use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1130-1Tivicay30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1130TIVICAY (DOLUTEGRAVIR SODIUM) TABLET, FILM COATED [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190125_807b0cd2-093c-4353-a4a5-2e1f264616ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
53808-1130-15380811300130 TABLET, FILM COATED in 1 BLISTER PACK (53808-1130-1) 2017-07-100000-00-00NoNoCurrent