NDC 0615-8197

Risperidone

Risperidone

Risperidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Risperidone.

Product ID0615-8197_0634f8ea-fe7b-4c8f-8801-176018c486ef
NDC0615-8197
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA077493
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0615-8197-05

15 TABLET in 1 BLISTER PACK (0615-8197-05)
Marketing Start Date2018-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8197-05 [00615819705]

Risperidone TABLET
Marketing CategoryANDA
Application NumberANDA077493
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-28

NDC 0615-8197-39 [00615819739]

Risperidone TABLET
Marketing CategoryANDA
Application NumberANDA077493
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-28

NDC 0615-8197-30 [00615819730]

Risperidone TABLET
Marketing CategoryANDA
Application NumberANDA077493
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.5 mg/1

OpenFDA Data

SPL SET ID:7bbc37f1-6d6a-4021-8976-1f103ce1cfbd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312832
  • 312830
  • 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
    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

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