NDC 0781-5310

Risperidone

Risperidone

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

Product ID0781-5310_0ca9e8a6-9431-469a-97e2-f57b7e3fe57e
NDC0781-5310
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2009-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA078116
Labeler NameSandoz Inc
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-5310-08

28 BLISTER PACK in 1 CARTON (0781-5310-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5310-06)
Marketing Start Date2009-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5310-08 [00781531008]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078116
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-22

NDC 0781-5310-06 [00781531006]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078116
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-17

NDC 0781-5310-64 [00781531064]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078116
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-22
Marketing End Date2016-05-06

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.5 mg/1

OpenFDA Data

SPL SET ID:e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 401953
  • 616705
  • 403825
  • 616698
  • 401954
  • UPC Code
  • 0307815313081
  • 0307815312084
  • 0307815310080
  • 0307815311087
  • 0307815314088
  • 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

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