Home NDC 54482-035-02 CYSTARAN
Product NDC 54482-035
Requested package NDC 54482-035-02
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 44 .
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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N200740-001 CYSTARAN EQ 0.44% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-10-02 3a93d1ddd44b…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N200740-001 ODE-31 2019-10-02 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N200740-001 ODE-31 2019-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N200740-001 ODE-31 2019-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N200740-001 ODE-31 2019-10-02 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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