Tivicay PD
These 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 TIVICAY PD (dolutegravir) tablets for oral suspensionInitial U.S. Approval: 2013
Approved
Approval ID
63df5af3-b8ac-4e76-9830-2dbb340af922
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2022
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dolutegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-255
Application NumberNDA213983
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolutegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (12)
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
DOLUTEGRAVIR SODIUMActive
Quantity: 5 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dolutegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-227
Application NumberNDA204790
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolutegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (11)
DOLUTEGRAVIR SODIUMActive
Quantity: 25 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
dolutegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-228
Application NumberNDA204790
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolutegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (11)
DOLUTEGRAVIR SODIUMActive
Quantity: 50 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
dolutegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-226
Application NumberNDA204790
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolutegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (10)
DOLUTEGRAVIR SODIUMActive
Quantity: 10 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT