NDC 50458-395

RISPERDAL M-TAB

Risperidone

RISPERDAL M-TAB is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Risperidone.

Product ID50458-395_22c3bebb-b2f7-4e8e-8877-d5c664e3f27f
NDC50458-395
Product TypeHuman Prescription Drug
Proprietary NameRISPERDAL M-TAB
Generic NameRisperidone
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2003-04-02
Marketing CategoryNDA / NDA
Application NumberNDA021444
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC SPL Data Element Entries

NDC 50458-395-30 [50458039530]

RISPERDAL M-TAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021444
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-04-02
Marketing End Date2017-05-30

NDC 50458-395-28 [50458039528]

RISPERDAL M-TAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021444
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-04-02
Marketing End Date2018-05-31

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.5 mg/1

OpenFDA Data

SPL SET ID:7e117c7e-02fc-4343-92a1-230061dfc5e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 630974
  • 630890
  • 211489
  • 806299
  • 314211
  • 199387
  • 312831
  • 312830
  • 312832
  • 616698
  • 616705
  • 262222
  • 806297
  • 403825
  • 806298
  • 262077
  • 401953
  • 401954
  • 104784
  • 104781
  • 104782
  • 104783
  • 312828
  • 312829

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "RISPERDAL M-TAB" or generic name "Risperidone"

    NDCBrand NameGeneric Name
    50458-335RISPERDAL M-TABRISPERDAL M-TAB
    50458-355RISPERDAL M-TABRISPERDAL M-TAB
    50458-315RISPERDAL M-TABRISPERDAL M-TAB
    50458-325RISPERDAL M-TABRISPERDAL M-TAB
    50458-395RISPERDAL M-TABRISPERDAL M-TAB
    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

    Trademark Results [RISPERDAL M-TAB]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RISPERDAL M-TAB
    RISPERDAL M-TAB
    85006963 4058343 Dead/Cancelled
    JOHNSON & JOHNSON
    2010-04-06
    RISPERDAL M-TAB
    RISPERDAL M-TAB
    78239521 2868025 Dead/Cancelled
    Johnson & Johnson
    2003-04-18
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