FDA.reportPublic FDA data

CYSTARAN

Product NDC
54482-020
11-digit product format
544820020
Labeler code
54482
Product ID
54482-020_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

Additional Listing Data#

Finished product
Yes
Brand name base
CYSTARAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYSTEAMINE HYDROCHLORIDE6.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIF1B771SVB
Rxcui1313780, 1313785

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd012da9-cd07-4d66-b6f1-ce3bdc2a3665Product name120210312
3d59dc1e-80a4-4b1f-b3e1-387c65c31efbProduct name320200619
a4fffefe-232a-3e06-c77d-1e6fdaec7d5eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54482-020-01CYSTARAN15 mL in 1 BOTTLESOLUTION1523
54482-020-02CYSTARAN15 mL in 1 BOTTLESOLUTION1523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54482-020-01ML - Milliliter54482-020ae9d1605-b4a9-499f-8aa0-a2ab1756dfc512013-05-02
54482-020-02ML - Milliliter54482-020b26d95d3-ef7d-4208-939e-57ae8683277712022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYSTEAMINE HYDROCHLORIDEACTIVE INGREDIENTIF1B771SVBCYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
CYSTEAMINEACTIVE MOIETY5UX2SD1KE2CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RCYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54482-020CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [LEADIANT BIOSCIENCES, INC.]23Current NDC, Legacy NDC, 2 package rows20250504_b98ee838-ed23-42a9-93b5-72579e490fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313785cystaran 0.44 % Ophthalmic SolutionPSNb98ee838-ed23-42a9-93b5-72579e490fba23
1313780cysteamine HCl 0.44 % Ophthalmic SolutionPSNb98ee838-ed23-42a9-93b5-72579e490fba23
1313785cysteamine 4.4 MG/ML Ophthalmic Solution [Cystaran]SBDb98ee838-ed23-42a9-93b5-72579e490fba23
1313780cysteamine 4.4 MG/ML Ophthalmic SolutionSCDb98ee838-ed23-42a9-93b5-72579e490fba23
1313785Cystaran 0.44 % Ophthalmic SolutionSYb98ee838-ed23-42a9-93b5-72579e490fba23
1313785Cystaran 4.4 MG/ML (cysteamine hydrochloride 6.5 MG/ML) Ophthalmic SolutionSYb98ee838-ed23-42a9-93b5-72579e490fba23
1313785Cystaran 4.4 MG/ML Ophthalmic SolutionSYb98ee838-ed23-42a9-93b5-72579e490fba23
1313780cysteamine 0.44 % Ophthalmic SolutionSYb98ee838-ed23-42a9-93b5-72579e490fba23
1313780cysteamine 4.4 MG/ML (as cysteamine hydrochloride 6.5 MG/ML) Ophthalmic SolutionSYb98ee838-ed23-42a9-93b5-72579e490fba23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54482-020-015448200200115 mL in 1 BOTTLE (54482-020-01) 15 ml2012-12-300000-00-00NoNoCurrent
54482-020-025448200200215 mL in 1 BOTTLE (54482-020-02) 15 ml2022-02-250000-00-00NoNoCurrent