FDA.reportPublic FDA data

PROCYSBI

Product NDC
75987-100
11-digit product format
759870100
Labeler code
75987
Product ID
75987-100_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cysteamine bitartrate
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA203389
Marketing category
NDA
Marketing start
2013-04-30
Substance
CYSTEAMINE BITARTRATE
Active strength
25 mg/1
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
PROCYSBI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYSTEAMINE BITARTRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQO84GZ3TST
Rxcui1421467, 1421473, 1421475, 1421477, 2284510, 2284514, 2284515, 2284516

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
75987-100-04PROCYSBI60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-100-04EA - Each75987-10015640ef3-4d9b-4832-b754-26ed2546364e12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-100PROCYSBI (CYSTEAMINE BITARTRATE) CAPSULE, DELAYED RELEASE PELLETS PROCYSBI (CYSTEAMINE BITARTRATE) GRANULE, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]12Current NDC, Legacy NDC, 1 package rows20250423_d3a3ec28-f746-463a-bb92-3bc8826db09e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421467cysteamine 25 MG Delayed Release Oral CapsulePSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284510cysteamine 300 MG Delayed Release Oral GranulesPSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421475cysteamine 75 MG Delayed Release Oral CapsulePSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284515cysteamine 75 MG Delayed Release Oral GranulesPSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421473PROCYSBI 25 MG Delayed Release Oral CapsulePSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284514PROCYSBI 300 MG Delayed Release Oral GranulesPSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421477PROCYSBI 75 MG Delayed Release Oral CapsulePSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284516PROCYSBI 75 MG Delayed Release Oral GranulesPSNd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421473cysteamine 25 MG Delayed Release Oral Capsule [Procysbi]SBDd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284514cysteamine 300 MG Delayed Release Oral Granules [Procysbi]SBDd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421477cysteamine 75 MG Delayed Release Oral Capsule [Procysbi]SBDd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284516cysteamine 75 MG Delayed Release Oral Granules [Procysbi]SBDd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421467cysteamine 25 MG Delayed Release Oral CapsuleSCDd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284510cysteamine 300 MG Delayed Release Oral GranulesSCDd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421475cysteamine 75 MG Delayed Release Oral CapsuleSCDd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284515cysteamine 75 MG Delayed Release Oral GranulesSCDd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284510cysteamin (as cysteamine bitartrate) 300 MG Delayed Release Oral GranulesSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284515cysteamine (as cysteamine bitartrate) 75 MG Delayed Release Oral GranulesSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421467cysteamine 25 MG (as cysteamine bitartrate 74 mg) Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421475cysteamine 75 MG (as cysteamine bitartrate 221 MG) Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421473Procysbi (cysteamine 25 MG (as cysteamine bitartrate 74 MG)) Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421477Procysbi (cysteamine 75 MG (as cysteamine bitartrate 221 MG)) Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421473Procysbi 25 MG Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284514Procysbi 300 MG Delayed Release Oral GranulesSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
1421477Procysbi 75 MG Delayed Release Oral CapsuleSYd3a3ec28-f746-463a-bb92-3bc8826db09e12
2284516Procysbi 75 MG Delayed Release Oral GranulesSYd3a3ec28-f746-463a-bb92-3bc8826db09e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75987-100-047598701000460 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04) 2013-04-300000-00-00NoNoCurrent