Quick answers
- What is Emtricitabine/TDF?
- Emtricitabine/TDF is a brand name of Emtricitabine and tenofovir disoproxil fumarate, a prescription medicine. The FDA NDC Directory lists 1 Emtricitabine/TDF product in 1 strength and form.
- Who makes Emtricitabine/TDF?
- Aurobindo Pharma holds the FDA application for Emtricitabine/TDF (ANDA090513, approved January 26, 2018).
- Is there a generic or store brand of Emtricitabine/TDF?
- Yes. The FDA NDC Directory lists 30 other products with the same active ingredients, strength and form as a Emtricitabine/TDF product, 28 of them generic. Ask your pharmacist whether one is right for you.
- Has Emtricitabine/TDF been recalled?
- No recall linked to Emtricitabine/TDF products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Emtricitabine/TDF is
Each Emtricitabine/TDF product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Emtricitabine and tenofovir disoproxil fumarate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| emtricitabine 200 mg · tenofovir disoproxil fumarate 300 mg tablet, film coated (oral) | Emtricitabine/TDF | 30 products, 22 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Emtricitabine and tenofovir disoproxil fumarate →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA090513 | Aurobindo Pharma | January 26, 2018 | 1 |
Companies that list Emtricitabine/TDF
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Emtricitabine/TDF products.
- Direct_Rx1 product
Recalls
No recall linked to Emtricitabine/TDF products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.