NDC 0054-0063

Risperidone

Risperidone

Risperidone is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Risperidone.

Product ID0054-0063_17e8a4f1-a665-4e29-acb8-2e04bcdbd790
NDC0054-0063
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2009-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA076904
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0054-0063-44

30 mL in 1 BOTTLE (0054-0063-44)
Marketing Start Date2009-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0063-44 [00054006344]

Risperidone SOLUTION
Marketing CategoryANDA
Application NumberANDA076904
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-29

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE1 mg/mL

OpenFDA Data

SPL SET ID:cd742c16-c003-4c4c-8fa0-a3b4d0158383
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199387
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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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