Stribild Access
These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2012
Approved
Approval ID
d52f7766-068f-4a2f-b748-356ff60450f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2021
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1202
Product Classification
G
Generic Name
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2018
FDA Product Classification
INGREDIENTS (16)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ELVITEGRAVIRActive
Quantity: 150 mg in 1 1
Code: 4GDQ854U53
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
COBICISTATActive
Quantity: 150 mg in 1 1
Code: LW2E03M5PG
Classification: ACTIB
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT