Package 54482-035-02

Brand: cystaran

Generic: cysteamine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 54482-035-02
Digits Only 5448203502
Product NDC 54482-035
Product ID 54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297
Description

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

Marketing

Marketing Status
Marketed Since 2025-04-25
Brand cystaran
Generic cysteamine hydrochloride
Sample Package No

Linked Drug Pages (1)

CYSTARAN ndc-match (0.95)

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"}