Active ingredient
Cyclopentolate
5 finished FDA listings contain Cyclopentolate as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CYCLOPENTOLATE HYDROCHLORIDE
- Dosage forms
- Solution, Solution/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/ml · 20 mg/ml · 5 mg/ml
- Brand names in FDA listings
- Cyclogyl
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3001
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 084110 | ALCON LABS INC | 1974-07-31 | 2 |
| ANDA 084108 | ALCON LABS INC | 1974-07-31 | 1 |
| ANDA 084109 | ALCON LABS INC | 1974-07-31 | 1 |
| ANDA 040075 | BAUSCH AND LOMB INC | 1994-04-29 | 1 |
Official labeling on DailyMed
- CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] · version 15 · 2024-06-27
- CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 15 · 2022-10-05
- CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [SANDOZ INC.] · version 7 · 2022-06-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.