Juluca
These highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA. JULUCA (dolutegravir and rilpivirine tablets), for oral useInitial U.S. Approval: 2017
Approved
Approval ID
806653d1-bf35-4924-b999-ad5d21821cc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2022
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dolutegravir sodium and rilpivirine hydrochloride
PRODUCT DETAILS
NDC Product Code49702-242
Application NumberNDA210192
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 21, 2017
Generic Namedolutegravir sodium and rilpivirine hydrochloride
INGREDIENTS (10)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
DOLUTEGRAVIR SODIUMActive
Quantity: 50 mg in 1 1
Code: 1Q1V9V5WYQ
Classification: ACTIM
RILPIVIRINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 212WAX8KDD
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT