cystaran

Generic: cysteamine hydrochloride

Labeler: leadiant biosciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cystaran
Generic Name cysteamine hydrochloride
Labeler leadiant biosciences, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

cysteamine hydrochloride 6.5 mg/mL

Manufacturer
Leadiant Biosciences, Inc.

Identifiers & Regulatory

Product NDC 54482-035
Product ID 54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200740
Listing Expiration 2026-12-31
Marketing Start 2012-12-30

Pharmacologic Class

Classes
cystine depleting agent [epc] cystine disulfide reduction [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54482035
Hyphenated Format 54482-035

Supplemental Identifiers

RxCUI
1313780 1313785
UNII
IF1B771SVB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cystaran (source: ndc)
Generic Name cysteamine hydrochloride (source: ndc)
Application Number NDA200740 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 6.5 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (54482-035-02)
source: ndc

Packages (1)

54482-035-02 15 mL in 1 BOTTLE (54482-035-02)

Ingredients (1)

cysteamine hydrochloride (6.5 mg/mL)

Linked Drug Pages (1)

CYSTARAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0ae95603-411c-455b-8bb8-8c5b01dac297", "openfda": {"unii": ["IF1B771SVB"], "rxcui": ["1313780", "1313785"], "spl_set_id": ["b98ee838-ed23-42a9-93b5-72579e490fba"], "manufacturer_name": ["Leadiant Biosciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (54482-035-02)", "package_ndc": "54482-035-02", "marketing_start_date": "20250425"}], "brand_name": "CYSTARAN", "product_id": "54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297", "dosage_form": "SOLUTION", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "54482-035", "generic_name": "cysteamine hydrochloride", "labeler_name": "Leadiant Biosciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYSTARAN", "active_ingredients": [{"name": "CYSTEAMINE HYDROCHLORIDE", "strength": "6.5 mg/mL"}], "application_number": "NDA200740", "marketing_category": "NDA", "marketing_start_date": "20121230", "listing_expiration_date": "20261231"}