Home NDC 54482-035 CYSTARAN
Product NDC 54482-035
11-digit product format 544820035
Labeler code 54482
Product ID 54482-035_0ae95603-411c-455b-8bb8-8c5b01dac297
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cysteamine hydrochloride
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Leadiant Biosciences, Inc.
Application NDA200740
Marketing category NDA
Marketing start 2012-12-30
Substance CYSTEAMINE HYDROCHLORIDE
Active strength 6.5 mg/mL
Pharmacologic classes Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200740-001 CYSTARAN CYSTEAMINE HYDROCHLORIDE EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CYSTARAN CYSTEAMINE HYDROCHLORIDE Leadiant Biosciences, Inc. b98ee838-ed23-42a9-93b5-72579e490fba 2025-04-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 200740 application number: NDA200740 ndc (product): 54482-035
Additional Listing Data#
Finished product Yes
Brand name base CYSTARAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IF1B771SVB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1313780 Internal RxNorm lookup 1313785 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54482-035-02 CYSTARAN 15 mL in 1 BOTTLE SOLUTION 15 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54482-035 CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [LEADIANT BIOSCIENCES, INC.] 23 Current NDC, 1 package rows 20250504_b98ee838-ed23-42a9-93b5-72579e490fba.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54482-035-02 54482003502 15 mL in 1 BOTTLE (54482-035-02) 15 ml 2025-04-25 No No Current