ODEFSEY
These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016
Approved
Approval ID
ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
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.
emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-2101
Application NumberNDA208351
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (15)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
RILPIVIRINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 212WAX8KDD
Classification: ACTIM
TENOFOVIR ALAFENAMIDE FUMARATEActive
Quantity: 25 mg in 1 1
Code: FWF6Q91TZO
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 9/17/2021
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 9/17/2021
RECENT MAJOR CHANGES
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Warnings and Precautions, New Onset or Worsening Renal Impairment (5.5) |
03/2021 |