Intelence
These highlights do not include all the information needed to use INTELENCE safely and effectively. See full prescribing information for INTELENCE. INTELENCE (etravirine) tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
6a9cbc29-9f15-4b24-8d86-206b82887f3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Janssen Products LP
DUNS: 804684207
Products 3
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 Code59676-570
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETRAVIRINEActive
Quantity: 100 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-571
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETRAVIRINEActive
Quantity: 200 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
etravirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-572
Application NumberNDA022187
Product Classification
M
Marketing Category
C73594
G
Generic Name
etravirine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETRAVIRINEActive
Quantity: 25 mg in 1 1
Code: 0C50HW4FO1
Classification: ACTIB