Stribild
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 useInitial U.S. Approval: 2012
Approved
Approval ID
8ac4d501-7f05-426e-93be-a42240087b0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
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 Code69189-1201
Application NumberNDA203100
Product Classification
M
Marketing Category
C73594
G
Generic Name
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 20, 2017
FDA Product Classification
INGREDIENTS (18)
elvitegravirActive
Quantity: 150 mg in 1 1
Code: 4GDQ854U53
Classification: ACTIB
tenofovir disoproxil fumarateActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
emtricitabineActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
cobicistatActive
Quantity: 150 mg in 1 1
Code: LW2E03M5PG
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT