RISPERDAL

These highlights do not include all the information needed to use RISPERDAL safely and effectively. See full prescribing information for RISPERDAL. RISPERDAL (risperidone) tablets, for oral use RISPERDAL (risperidone) oral solution RISPERDAL M-TAB (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993

Approved

Approval ID

7e117c7e-02fc-4343-92a1-230061dfc5e0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2022

Manufacturers

FDA

Janssen Pharmaceuticals, Inc.

DUNS: 063137772

Products 10

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 Code50458-335

Application NumberNDA021444

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (10)

risperidoneActive

Quantity: 3 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

glycineInactive

Code: TE7660XO1C

Classification: IACT

gelatin, unspecifiedInactive

Code: 2G86QN327L

Classification: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27E

Classification: IACT

aspartameInactive

Code: Z0H242BBR1

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

peppermint oilInactive

Code: AV092KU4JH

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

sodium hydroxideInactive

Code: 55X04QC32I

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-350

Application NumberNDA020272

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (14)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

risperidoneActive

Quantity: 4 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

microcrystalline celluloseInactive

Code: OP1R32D61U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Aluminum OxideInactive

Code: LMI26O6933

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-325

Application NumberNDA021444

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (10)

risperidoneActive

Quantity: 2 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

glycineInactive

Code: TE7660XO1C

Classification: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27E

Classification: IACT

sodium hydroxideInactive

Code: 55X04QC32I

Classification: IACT

aspartameInactive

Code: Z0H242BBR1

Classification: IACT

peppermint oilInactive

Code: AV092KU4JH

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

gelatin, unspecifiedInactive

Code: 2G86QN327L

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-395

Application NumberNDA021444

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (9)

gelatin, unspecifiedInactive

Code: 2G86QN327L

Classification: IACT

risperidoneActive

Quantity: 0.5 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

glycineInactive

Code: TE7660XO1C

Classification: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27E

Classification: IACT

sodium hydroxideInactive

Code: 55X04QC32I

Classification: IACT

aspartameInactive

Code: Z0H242BBR1

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

peppermint oilInactive

Code: AV092KU4JH

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-300

Application NumberNDA020272

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (9)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

risperidoneActive

Quantity: 1 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

microcrystalline celluloseInactive

Code: OP1R32D61U

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-305

Application NumberNDA020588

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (5)

risperidoneActive

Quantity: 1 mg in 1 mL

Code: L6UH7ZF8HC

Classification: ACTIB

tartaric acidInactive

Code: W4888I119H

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

sodium hydroxideInactive

Code: 55X04QC32I

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-330

Application NumberNDA020272

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (12)

risperidoneActive

Quantity: 3 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

microcrystalline celluloseInactive

Code: OP1R32D61U

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-355

Application NumberNDA021444

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (10)

risperidoneActive

Quantity: 4 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

mannitolInactive

Code: 3OWL53L36A

Classification: IACT

gelatin, unspecifiedInactive

Code: 2G86QN327L

Classification: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27E

Classification: IACT

glycineInactive

Code: TE7660XO1C

Classification: IACT

sodium hydroxideInactive

Code: 55X04QC32I

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

aspartameInactive

Code: Z0H242BBR1

Classification: IACT

peppermint oilInactive

Code: AV092KU4JH

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-320

Application NumberNDA020272

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (13)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

risperidoneActive

Quantity: 2 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Aluminum OxideInactive

Code: LMI26O6933

Classification: IACT

microcrystalline celluloseInactive

Code: OP1R32D61U

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

risperidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-302

Application NumberNDA020272

Product Classification

Marketing Category

C73594

Generic Name

risperidone

Product Specifications

Route of AdministrationORAL

Effective DateAugust 31, 2022

FDA Product Classification

INGREDIENTS (12)

hypromellose, unspecifiedInactive

Code: 3NXW29V3WO

Classification: IACT

risperidoneActive

Quantity: 0.5 mg in 1 1

Code: L6UH7ZF8HC

Classification: ACTIB

anhydrous lactoseInactive

Code: 3SY5LH9PMK

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

propylene glycolInactive

Code: 6DC9Q167V3

Classification: IACT

microcrystalline celluloseInactive

Code: OP1R32D61U

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

ferric oxide redInactive

Code: 1K09F3G675

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

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RISPERDAL

Products 10

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (5)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

risperidone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

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