NDC 55648-557

RISPERIDONE

Risperidone

RISPERIDONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Risperidone.

Product ID55648-557_aaa62d0c-37d5-40a9-8940-2f2b7397197f
NDC55648-557
Product TypeHuman Prescription Drug
Proprietary NameRISPERIDONE
Generic NameRisperidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA078871
Labeler NameWOCKHARDT LIMITED
Substance NameRISPERIDONE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-557-04

60 TABLET, FILM COATED in 1 BOTTLE (55648-557-04)
Marketing Start Date2008-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-557-04 [55648055704]

RISPERIDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078871
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-09
Inactivation Date2020-01-31

NDC 55648-557-02 [55648055702]

RISPERIDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078871
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-09
Inactivation Date2020-01-31

NDC 55648-557-01 [55648055701]

RISPERIDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078871
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-09
Inactivation Date2020-01-31

NDC 55648-557-03 [55648055703]

RISPERIDONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078871
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE2 mg/1

OpenFDA Data

SPL SET ID:e92a97ef-0fe3-40b1-a938-373293a75255
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314211
  • 312831
  • 312830
  • 312832
  • 312828
  • 312829
  • UPC Code
  • 0364679572023
  • 0364679553046
  • 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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