NDC 54482-035 – Cystaran
Cysteamine Hydrochloride 6.5 mg/mL · Solution · Ophthalmic
Product NDC54482-035
Product details
- Brand name
- Cystaran
- Generic name
- Cysteamine hydrochloride
- Labeler
- Leadiant Biosciences, Inc.
- Dosage form
- Solution
- Route
- Ophthalmic
- Marketing category
- NDA · NDA200740
- Marketed since
- December 30, 2012
- Listing expires
- December 31, 2026
- Pharmacologic class
- Cystine Depleting Agent
Active ingredients
- Cysteamine Hydrochloride 6.5 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 54482-035-02 | 15 mL in 1 BOTTLE (54482-035-02) | Apr 25, 2025 |
Recalls mentioning this NDC
- D-0034-2021 Oct 21, 2020 · Class III
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. - D-0683-2018 Apr 25, 2018 · Class III
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. - D-0550-2018 Mar 7, 2018 · Class III
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Other Cystaran products
- 54482-020 Cysteamine Hydrochloride 6.5 mg/mL · Solution · Leadiant Biosciences, Inc.