Active ingredient
Tetradecyl Hydrogen Sulfate (Ester)
4 finished FDA listings contain Tetradecyl Hydrogen Sulfate (Ester) as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TETRADECYL HYDROGEN SULFATE (ESTER)
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/ml · 30 mg/ml
- Brand names in FDA listings
- Sotradecol
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1370424
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 |
|---|---|---|---|
| ANDA 040541 | MYLAN INSTITUTIONAL | 2004-11-12 | 4 |
Official labeling on DailyMed
- SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2024-02-27
- SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 12 · 2021-11-30
- (SOTRADECOL) SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 1 · 2021-06-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.