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Risperidone

These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993

Approved
Approval ID

701e1cd8-2868-4d29-85a9-a2212c88165f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2022

Manufacturers
FDA

Janssen Pharmaceutical, 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

NDC Product Code50458-596
Application NumberNDA020588
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (5)

risperidoneActive
Quantity: 1 mg in 1 mL
Code: L6UH7ZF8HC
Classification: ACTIB
tartaric acidInactive
Code: W4888I119H
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-593
Application NumberNDA020272
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (13)

risperidoneActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
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
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-602
Application NumberNDA021444
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (9)

risperidoneActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT
carbomer homopolymer type c (allyl pentaerythritol crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
peppermint oilInactive
Code: AV092KU4JH
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-601
Application NumberNDA021444
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (9)

risperidoneActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
peppermint oilInactive
Code: AV092KU4JH
Classification: IACT
carbomer homopolymer type c (allyl pentaerythritol crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-605
Application NumberNDA021444
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (10)

risperidoneActive
Quantity: 4 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT
carbomer homopolymer type c (allyl pentaerythritol crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
peppermint oilInactive
Code: AV092KU4JH
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-603
Application NumberNDA021444
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (10)

risperidoneActive
Quantity: 2 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
carbomer homopolymer type c (allyl pentaerythritol crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
peppermint oilInactive
Code: AV092KU4JH
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-604
Application NumberNDA021444
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (10)

risperidoneActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
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
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
peppermint oilInactive
Code: AV092KU4JH
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-594
Application NumberNDA020272
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (12)

anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
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
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
risperidoneActive
Quantity: 3 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-591
Application NumberNDA020272
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (12)

risperidoneActive
Quantity: 0.5 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
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
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT

risperidone

PRODUCT DETAILS

NDC Product Code50458-592
Application NumberNDA020272
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 14, 2022
Generic Namerisperidone

INGREDIENTS (9)

risperidoneActive
Quantity: 1 mg in 1 1
Code: L6UH7ZF8HC
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
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