CYSTARAN
- Product NDC
- 54482-035
- 11-digit product format
- 544820035
- Labeler code
- 54482
- Product ID
- 54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cysteamine hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Leadiant Biosciences, Inc.
- Application
- NDA200740
- Marketing category
- NDA
- Marketing start
- 2012-12-30
- Substance
- CYSTEAMINE HYDROCHLORIDE
- Active strength
- 6.5 mg/mL
- Pharmacologic classes
- Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| IF1B771SVB | CYSTEAMINE HYDROCHLORIDE | 156-57-0 | CYSTEAMINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 54482-035-02 | 54482003502 | 15 mL in 1 BOTTLE (54482-035-02) | 15 ml | 2025-04-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| CYSTARAN | Leadiant Biosciences, Inc. | 2025-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 23 |