Emtricitabine/TDF
Emtricitabine/TDF is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Emtricitabine/TDF. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- Emtricitabine/TDF
- Brand Names
- Emtricitabine/TDF
- Application Number
- ANDA090513
- Sponsor
- Direct_Rx
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE
Indications and Usage
1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see CLINICAL STUDIES (14)]. 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.2)].