NDC 54482-020

CYSTARAN

Cysteamine Hydrochloride

CYSTARAN is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Leadiant Biosciences, Inc.. The primary component is Cysteamine Hydrochloride.

• Product ID: 54482-020_626d1e1b-6394-4d4e-b13f-ef4d96b89ba0
• NDC: 54482-020
• Product Type: Human Prescription Drug
• Proprietary Name: CYSTARAN
• Generic Name: Cysteamine Hydrochloride
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2012-12-30
• Marketing Category: NDA / NDA
• Application Number: NDA200740
• Labeler Name: Leadiant Biosciences, Inc.
• Substance Name: CYSTEAMINE HYDROCHLORIDE
• Active Ingredient Strength: 7 mg/mL
• Pharm Classes: Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 54482-020-02

15 mL in 1 BOTTLE (54482-020-02)

• Marketing Start Date: 2022-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54482-020-01 [54482002001]

CYSTARAN SOLUTION

• Marketing Category: NDA
• Application Number: NDA200740
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-12-30

Drug Details

Active Ingredients

Ingredient	Strength
CYSTEAMINE HYDROCHLORIDE	6.5 mg/mL

OpenFDA Data

• SPL SET ID: b98ee838-ed23-42a9-93b5-72579e490fba
• Manufacturer:
  • Leadiant Biosciences, Inc.
• UNII:
  • IF1B771SVB
• RxNorm Concept Unique ID - RxCUI:
  • 1313780
  • 1313785

Pharmacological Class

• Cystine Depleting Agent [EPC]
• Cystine Disulfide Reduction [MoA]

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

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