NDC 17856-0380

Risperidone

Risperidone

Risperidone is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Risperidone.

Product ID17856-0380_09287282-1b8e-4c4d-a32f-193630499b8e
NDC17856-0380
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA091384
Labeler NameAtlantic Biologicals Corps
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0380-2

2 mL in 1 SYRINGE (17856-0380-2)
Marketing Start Date2011-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0380-1 [17856038001]

Risperidone SOLUTION
Marketing CategoryANDA
Application NumberANDA091384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2020-01-31

NDC 17856-0380-2 [17856038002]

Risperidone SOLUTION
Marketing CategoryANDA
Application NumberANDA091384
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE1 mg/mL

OpenFDA Data

SPL SET ID:dae5ec58-85c1-4503-a6b8-56696dd1e6fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199387
  • 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.