FDA.reportPublic FDA data

PROCYSBI

Product NDC
75987-145
11-digit product format
759870145
Labeler code
75987
Product ID
75987-145_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cysteamine bitartrate
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA213491
Marketing category
NDA
Marketing start
2020-02-14
Substance
CYSTEAMINE BITARTRATE
Active strength
300 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 BITARTRATE300 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
75987-145-13PROCYSBI1 in 1 PACKETGRANULE, DELAYED RELEASE112
75987-145-13PROCYSBI60 in 1 CARTONGRANULE, DELAYED RELEASE6012
75987-145-14PROCYSBI120 in 1 CARTONGRANULE, DELAYED RELEASE12012
75987-145-14PROCYSBI1 in 1 PACKETGRANULE, DELAYED RELEASE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-145-13EA - Each75987-145b04933e6-9664-474a-8464-c60d53f3ca5612020-04-20
75987-145-14EA - Each75987-14507f43bbe-cfaf-4934-bd0c-a08dc78d3cf612020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-145PROCYSBI (CYSTEAMINE BITARTRATE) CAPSULE, DELAYED RELEASE PELLETS PROCYSBI (CYSTEAMINE BITARTRATE) GRANULE, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]12Current NDC, Legacy NDC, 4 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-145-137598701451360 PACKET in 1 CARTON (75987-145-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET60 packet2020-02-140000-00-00NoNoCurrent
75987-145-1475987014514120 PACKET in 1 CARTON (75987-145-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET120 packet2020-02-140000-00-00NoNoCurrent