Quick answers
- What is Sotradecol?
- Sotradecol is a brand name of Tetradecyl hydrogen sulfate (ester), a prescription medicine. The FDA NDC Directory lists 2 Sotradecol products in 2 strengths and forms.
- Who makes Sotradecol?
- Mylan Institutional holds the FDA application for Sotradecol (ANDA040541, approved November 12, 2004).
- Is there a generic or store brand of Sotradecol?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Sotradecol product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Sotradecol been recalled?
- No recall linked to Sotradecol products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Sotradecol is
Each Sotradecol 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.
Tetradecyl hydrogen sulfate (ester) · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tetradecyl hydrogen sulfate (ester) 10 mg/mL injection, solution (intravenous) | Sotradecol | 1 product, 1 company | DailyMed |
| tetradecyl hydrogen sulfate (ester) 30 mg/mL injection, solution (intravenous) | Sotradecol | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tetradecyl hydrogen sulfate (ester) →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA040541 | Mylan Institutional | November 12, 2004 | 2 |
Companies that list Sotradecol
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sotradecol products.
- Mylan Institutional LLC2 products
Recalls
No recall linked to Sotradecol 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.