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PROCYSBI

These highlights do not include all the information needed to use PROCYSBI safely and effectively. See Full Prescribing Information for PROCYSBI. PROCYSBI (cysteamine bitartrate) delayed-release capsules, for oral use PROCYSBI (cysteamine bitartrate) delayed-release oral granules Initial U.S. Approval: 1994

Approved
Approval ID

d3a3ec28-f746-463a-bb92-3bc8826db09e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2022

Manufacturers
FDA

Horizon Therapeutics USA, Inc.

DUNS: 033470838

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cysteamine bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75987-100
Application NumberNDA203389
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification

INGREDIENTS (1)

CYSTEAMINE BITARTRATEActive
Quantity: 25 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM

Cysteamine bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75987-101
Application NumberNDA203389
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification

INGREDIENTS (1)

CYSTEAMINE BITARTRATEActive
Quantity: 75 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM

Cysteamine bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75987-145
Application NumberNDA213491
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification

INGREDIENTS (1)

CYSTEAMINE BITARTRATEActive
Quantity: 300 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM

Cysteamine bitartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75987-140
Application NumberNDA213491
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification

INGREDIENTS (1)

CYSTEAMINE BITARTRATEActive
Quantity: 75 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM

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