NDC 55292-410

CYSTADROPS

Cysteamine Hydrochloride

CYSTADROPS is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Cysteamine Hydrochloride.

• Product ID: 55292-410_14790aa9-d493-4d63-b24d-caf35230caf5
• NDC: 55292-410
• Product Type: Human Prescription Drug
• Proprietary Name: CYSTADROPS
• Generic Name: Cysteamine Hydrochloride
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2020-08-19
• Marketing Category: NDA / NDA
• Application Number: NDA211302
• Labeler Name: RECORDATI RARE DISEASES, INC.
• Substance Name: CYSTEAMINE HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/mL
• Pharm Classes: Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55292-410-05

1 BOTTLE, GLASS in 1 BOX (55292-410-05) > 5 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2020-08-19
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "CYSTADROPS" or generic name "Cysteamine Hydrochloride"

NDC	Brand Name	Generic Name
55292-410	CYSTADROPS	cysteamine hydrochloride
54482-020	CYSTARAN	cysteamine hydrochloride