NDC 50458-601

Risperidone M-TAB

Risperidone

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

Product ID50458-601_3e524f1e-7ea8-11e8-83da-f59c9d46d017
NDC50458-601
Product TypeHuman Prescription Drug
Proprietary NameRisperidone M-TAB
Generic NameRisperidone
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2003-04-02
Marketing CategoryNDA / NDA
Application NumberNDA021444
Labeler NameJanssen Pharmaceutical, Inc.
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-601-28

7 BLISTER PACK in 1 BOX (50458-601-28) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2003-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-601-30 [50458060130]

Risperidone M-TAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021444
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-04-02
Marketing End Date2018-01-31

NDC 50458-601-28 [50458060128]

Risperidone M-TAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021444
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-04-02
Marketing End Date2018-01-31

Drug Details

Active Ingredients

IngredientStrength
RISPERIDONE.5 mg/1

OpenFDA Data

SPL SET ID:701e1cd8-2868-4d29-85a9-a2212c88165f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 401953
  • 616698
  • 401954
  • 616705
  • 314211
  • 199387
  • 312831
  • 312830
  • 312832
  • 403825
  • 312828
  • 312829
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    50458060128 RISPERIDONE 0.5 MG ODT

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    50458-603Risperidone M-TABRisperidone M-TAB
    50458-601Risperidone M-TABRisperidone M-TAB
    50458-602Risperidone M-TABRisperidone 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

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