Etravirine

Basic Information

Product Name

Etravirine

FDA Product Code

10147-0570

Regulatory Information

NDC Product Code

10147-0570

Application Number

NDA022187

Marketing Category

C73594

Effective Date

March 26, 2025

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

ETRAVIRINE

Quantity: 100 mg in 1 1

Code: 0C50HW4FO1

Class Code: ACTIB

Active Moieties

Code: 0C50HW4FO1

Etravirine

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

MICROCRYSTALLINE CELLULOSE

CROSCARMELLOSE SODIUM

HYPROMELLOSE, UNSPECIFIED

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

Active Moieties

ETRAVIRINE