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 ID54482-020_626d1e1b-6394-4d4e-b13f-ef4d96b89ba0
NDC54482-020
Product TypeHuman Prescription Drug
Proprietary NameCYSTARAN
Generic NameCysteamine Hydrochloride
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2012-12-30
Marketing CategoryNDA / NDA
Application NumberNDA200740
Labeler NameLeadiant Biosciences, Inc.
Substance NameCYSTEAMINE HYDROCHLORIDE
Active Ingredient Strength7 mg/mL
Pharm ClassesCystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 54482-020-02

15 mL in 1 BOTTLE (54482-020-02)
Marketing Start Date2022-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54482-020-01 [54482002001]

CYSTARAN SOLUTION
Marketing CategoryNDA
Application NumberNDA200740
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-12-30

Drug Details

Active Ingredients

IngredientStrength
CYSTEAMINE HYDROCHLORIDE6.5 mg/mL

OpenFDA Data

SPL SET ID:b98ee838-ed23-42a9-93b5-72579e490fba
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    54482-020CYSTARANcysteamine hydrochloride
    55292-410CYSTADROPScysteamine hydrochloride

    Trademark Results [CYSTARAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYSTARAN
    CYSTARAN
    85095017 4407365 Live/Registered
    LEADIANT BIOSCIENCES, INC.
    2010-07-28
    CYSTARAN
    CYSTARAN
    85089255 not registered Dead/Abandoned
    Sigma-Tau Pharmaceuticals, Inc.
    2010-07-21

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