NDC 68382-116

risperidone

Risperidone

risperidone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Risperidone.

Product ID68382-116_4b890083-4f7c-4a1a-9063-462c92e2f41a
NDC68382-116
Product TypeHuman Prescription Drug
Proprietary Namerisperidone
Generic NameRisperidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA078040
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameRISPERIDONE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-116-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-116-01)
Marketing Start Date2008-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-116-14 [68382011614]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-13

NDC 68382-116-05 [68382011605]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-13

NDC 68382-116-10 [68382011610]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-13

NDC 68382-116-01 [68382011601]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-13

NDC 68382-116-16 [68382011616]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-13

NDC 68382-116-06 [68382011606]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-11-13

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE3 mg/1

OpenFDA Data

SPL SET ID:713b5ac7-53d6-4139-8599-3028f789de4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314211
  • 312831
  • 312830
  • 312832
  • 312828
  • 312829
  • UPC Code
  • 0368382113146
  • 0368382112149
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    68382011614 RISPERIDONE 3 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382011605 RISPERIDONE 3 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.