Home NDC 55292-410 CYSTADROPS
Product NDC 55292-410
11-digit product format 552920410
Labeler code 55292
Product ID 55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cysteamine hydrochloride
Dosage form SOLUTION
Route OPHTHALMIC
Labeler RECORDATI RARE DISEASES, INC.
Application NDA211302
Marketing category NDA
Marketing start 2020-08-19
Substance CYSTEAMINE HYDROCHLORIDE
Active strength 3.5 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 42 .
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 N211302-001 CYSTADROPS CYSTEAMINE HYDROCHLORIDE EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19
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 2026-08-18 06:07:40 2026-07 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211302-001 CYSTADROPS EQ 0.37% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2020-08-19 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base CYSTADROPS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYSTEAMINE HYDROCHLORIDE 3.5 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 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 55292-410-05 CYSTADROPS 1 in 1 BOX SOLUTION 1 5 55292-410-05 CYSTADROPS 5 mL in 1 BOTTLE, GLASS SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55292-410 CYSTADROPS (CYSTEAMINE HYDROCHLORIDE) SOLUTION [RECORDATI RARE DISEASES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241004_5d2bcce3-9b89-4141-aeb7-db00449047f5.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55292-410-05 55292041005 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS 2020-08-19 0000-00-00 No No Current