NDC 63187-642

RISPERIDONE

Risperidone

RISPERIDONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Risperidone.

Product ID63187-642_cfc4d1cd-9c4f-449b-a449-98e4c320360d
NDC63187-642
Product TypeHuman Prescription Drug
Proprietary NameRISPERIDONE
Generic NameRisperidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-09-09
Marketing CategoryANDA / ANDA
Application NumberANDA201003
Labeler NameProficient Rx LP
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63187-642-30

30 TABLET in 1 BOTTLE (63187-642-30)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-642-30 [63187064230]

RISPERIDONE TABLET
Marketing CategoryANDA
Application NumberANDA201003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-642-90 [63187064290]

RISPERIDONE TABLET
Marketing CategoryANDA
Application NumberANDA201003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-642-60 [63187064260]

RISPERIDONE TABLET
Marketing CategoryANDA
Application NumberANDA201003
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.5 mg/1

OpenFDA Data

SPL SET ID:1b5c9889-4dc3-48df-8629-4ac099e2b4c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312829
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "RISPERIDONE" or generic name "Risperidone"

    NDCBrand NameGeneric Name
    0054-0063RisperidoneRisperidone
    0378-3502Risperidonerisperidone
    0378-3505Risperidonerisperidone
    0378-3511Risperidonerisperidone
    0378-3512Risperidonerisperidone
    0378-3513Risperidonerisperidone
    0378-3514Risperidonerisperidone
    0603-9424RisperidoneRisperidone
    0615-7505Risperidonerisperidone
    0615-7506Risperidonerisperidone
    0615-7507Risperidonerisperidone
    0615-8196RisperidoneRisperidone
    0615-8197RisperidoneRisperidone
    0615-8198RisperidoneRisperidone
    0615-8265RisperidoneRisperidone
    0615-8288RisperidoneRisperidone
    0781-5310RisperidoneRisperidone
    0781-5311RisperidoneRisperidone
    0781-5312RisperidoneRisperidone
    0781-5313RisperidoneRisperidone
    68071-2138risperidonerisperidone
    68071-3356RISPERIDONERISPERIDONE
    68071-3369risperidonerisperidone
    68071-4618RISPERIDONERISPERIDONE
    68084-271RisperidoneRisperidone
    68084-274RisperidoneRisperidone
    68084-270RisperidoneRisperidone
    68084-272RisperidoneRisperidone
    68084-277RisperidoneRisperidone
    68084-273RisperidoneRisperidone
    68151-0317RisperidoneRisperidone
    68382-112risperidonerisperidone
    68382-114risperidonerisperidone
    68382-113risperidonerisperidone
    68382-156risperidonerisperidone
    68382-116risperidonerisperidone
    68382-154risperidonerisperidone
    68382-117risperidonerisperidone
    68382-155risperidonerisperidone
    68382-115risperidonerisperidone
    68788-7211RISPERIDONERISPERIDONE
    70518-0364RISPERIDONERISPERIDONE
    70518-0979risperidonerisperidone
    70518-0978risperidonerisperidone
    70518-1575RISPERIDONERISPERIDONE
    70518-1613RISPERIDONERISPERIDONE
    70518-1151risperidonerisperidone
    70518-1502RISPERIDONERISPERIDONE
    70518-1631RISPERIDONERISPERIDONE
    70518-1574risperidonerisperidone

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.