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Risperidone

These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE.RISPERIDONE tablet for oral use Risperidone Tablets, USPInitial U.S. Approval:

Approved
Approval ID

2e8fb017-8754-421a-a76a-c41b8f48070b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 11, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 5

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

Risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-087
Application NumberANDA079088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification

INGREDIENTS (1)

RISPERIDONEActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB

Risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-089
Application NumberANDA079088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification

INGREDIENTS (1)

RISPERIDONEActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB

Risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-095
Application NumberANDA079088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification

INGREDIENTS (1)

RISPERIDONEActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB

Risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-096
Application NumberANDA079088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification

INGREDIENTS (1)

RISPERIDONEActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB

Risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-072
Application NumberANDA079088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification

INGREDIENTS (1)

RISPERIDONEActive
Quantity: 0.25 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB

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Risperidone - FDA Drug Approval Details