NDC 0615-7505

Risperidone

Risperidone

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

Product ID0615-7505_cb1c057c-97ba-43a2-aceb-b2d096af0f6d
NDC0615-7505
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-09-17
Marketing CategoryANDA / ANDA
Application NumberANDA076288
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameRISPERIDONE
Active Ingredient Strength0 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0615-7505-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7505-39)
Marketing Start Date2008-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7505-31 [00615750531]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-17
Marketing End Date2015-02-05

NDC 0615-7505-30 [00615750530]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-27
Marketing End Date2019-09-30

NDC 0615-7505-05 [00615750505]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-01
Marketing End Date2019-10-31

NDC 0615-7505-39 [00615750539]

Risperidone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076288
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-01
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.25 mg/1

OpenFDA Data

SPL SET ID:1fd9de6d-783b-47f3-b2b7-cb633b939494
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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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