NDC 51079-347

Risperidone

Risperidone

Risperidone is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Risperidone.

Product ID51079-347_7d8ee118-5731-08c9-e053-2a91aa0ae10f
NDC51079-347
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2011-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA091537
Labeler NameMylan Institutional Inc.
Substance NameRISPERIDONE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51079-347-05

20 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-347-05) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-347-01)
Marketing Start Date2011-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-347-05 [51079034705]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA091537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-10
Marketing End Date2017-09-30

NDC 51079-347-01 [51079034701]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA091537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-10
Marketing End Date2017-09-30

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE3 mg/1

OpenFDA Data

SPL SET ID:7073b706-1946-4ff2-8788-fb9452a59cae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 401953
  • 616698
  • 401954
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    51079034705 RISPERIDONE 3 MG ODT

    Pricing Unit: EA | Drug Type:

    51079034701 RISPERIDONE 3 MG ODT

    Pricing Unit: EA | Drug Type:

    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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