NDC 0378-3514

Risperidone

Risperidone

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

Product ID0378-3514_bd55c402-c772-4adf-a9cc-129ab7f67fee
NDC0378-3514
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-09-17
Marketing End Date2020-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA076288
Labeler NameMylan Pharmaceuticals Inc.
Substance NameRISPERIDONE
Active Ingredient Strength4 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-3514-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3514-91)
Marketing Start Date2008-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3514-01 [00378351401]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-17
Marketing End Date2014-09-15

NDC 0378-3514-91 [00378351491]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-09-17
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE4 mg/1

OpenFDA Data

SPL SET ID:1e4fe8ef-b215-be45-0793-c55af24db6bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314211
  • 312831
  • 312830
  • 312832
  • 312828
  • 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
    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

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.