Etravirine
These highlights do not include all the information needed to use Etravirine safely and effectively. See full prescribing information for Etravirine. Etravirine tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
50ca19cb-0f43-4d7b-8c9e-8b3aaded0546
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2025
Manufacturers
FDA
Patriot Pharmaceuticals
DUNS: 178220385
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0571
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2025
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETRAVIRINEActive
Quantity: 200 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0570
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2025
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETRAVIRINEActive
Quantity: 100 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB