# Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

NDC: 0378-5440
Generic name: Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Labeler / Manufacturer: Mylan Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET, FILM COATED
Routes: ORAL
Marketing started: 20250527

FDA application: ANDA208452

## Active ingredients

- EMTRICITABINE: 200 mg/1
- RILPIVIRINE HYDROCHLORIDE: 25 mg/1
- TENOFOVIR DISOPROXIL FUMARATE: 300 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0378-5440"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0378-5440
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d9a4185e-43fa-4aeb-9b0f-8db01b166038