Active ingredient
Emtricitabine
4 finished FDA listings contain Emtricitabine as their only active ingredient; 69 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- EMTRICITABINE
- Dosage forms
- Capsule, Solution
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/ml · 200 mg/1
- Brand names in FDA listings
- Emtriva
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 276237
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021500 | GILEAD | 2003-07-02 | 1 |
| NDA 021896 | GILEAD | 2005-09-28 | 1 |
| ANDA 091168 | CIPLA | 2018-07-02 | 1 |
| ANDA 079188 | AUROBINDO PHARMA LTD | 2023-03-15 | 1 |
Official labeling on DailyMed
- EMTRICITABINE CAPSULE [CIPLA USA INC.] · version 6 · 2026-08-24
- EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] · version 13 · 2025-12-22
- EMTRICITABINE CAPSULE [AUROBINDO PHARMA LIMITED] · version 2 · 2024-02-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.