NDC 49884-402

Risperidone

Risperidone

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

Product ID49884-402_05dfe34b-9904-4491-973e-7658e690970b
NDC49884-402
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA077494
Labeler NamePar Pharmaceutical, Inc.
Substance NameRISPERIDONE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 49884-402-91

7 BLISTER PACK in 1 CARTON (49884-402-91) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-402-52)
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-402-91 [49884040291]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA077494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01

NDC 49884-402-52 [49884040252]

Risperidone TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA077494
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-17

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE3 mg/1

OpenFDA Data

SPL SET ID:d0ef6df3-67e5-47b1-bcf7-f67aa030caca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 401953
  • 616698
  • 401954
  • 616705
  • 645037
  • 403825
  • UPC Code
  • 0349884212919
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    49884040291 RISPERIDONE 3 MG ODT

    Pricing Unit: EA | Drug Type:

    49884040252 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.