NDC 70518-0978

risperidone

Risperidone

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

Product ID70518-0978_63653dca-127f-3462-e053-2a91aa0ae6ce
NDC70518-0978
Product TypeHuman Prescription Drug
Proprietary Namerisperidone
Generic NameRisperidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA078040
Labeler NameREMEDYREPACK INC.
Substance NameRISPERIDONE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0978-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0978-0)
Marketing Start Date2018-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0978-0 [70518097800]

risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078040
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-22

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE2 mg/1

OpenFDA Data

SPL SET ID:6cbdaebd-274b-49fd-ba3d-eb9057856880
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312831
  • 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
    0781-5314RisperidoneRisperidone
    0904-6357RisperidoneRisperidone
    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

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