NDC 70518-1824

Latuda

Lurasidone Hydrochloride

Latuda is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Lurasidone Hydrochloride.

Product ID70518-1824_8403a99e-6f32-41c4-e053-2a91aa0a51ed
NDC70518-1824
Product TypeHuman Prescription Drug
Proprietary NameLatuda
Generic NameLurasidone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-24
Marketing CategoryNDA / NDA
Application NumberNDA200603
Labeler NameREMEDYREPACK INC.
Substance NameLURASIDONE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1824-0

30 POUCH in 1 BOX, UNIT-DOSE (70518-1824-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-1824-1)
Marketing Start Date2019-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1824-1 [70518182401]

Latuda TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA200603
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-24

NDC 70518-1824-0 [70518182400]

Latuda TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA200603
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-24

Drug Details

Active Ingredients

IngredientStrength
LURASIDONE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:de3e97ef-b1e1-4982-ac45-30dc5c9228cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1235247
  • 1235249

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Latuda" or generic name "Lurasidone Hydrochloride"

    NDCBrand NameGeneric Name
    63402-302Latudalurasidone hydrochloride
    63402-304Latudalurasidone hydrochloride
    63402-306Latudalurasidone hydrochloride
    63402-308Latudalurasidone hydrochloride
    63402-312Latudalurasidone hydrochloride
    70518-1812Latudalurasidone hydrochloride
    70518-1824LatudaLatuda
    70518-1936LatudaLatuda
    70518-3010LatudaLatuda
    13668-464Lurasidone HydrochlorideLurasidone Hydrochloride
    13668-465Lurasidone HydrochlorideLurasidone Hydrochloride
    13668-466Lurasidone HydrochlorideLurasidone Hydrochloride
    13668-467Lurasidone HydrochlorideLurasidone Hydrochloride
    46708-494Lurasidone HydrochlorideLurasidone Hydrochloride
    46708-495Lurasidone HydrochlorideLurasidone Hydrochloride
    46708-496Lurasidone HydrochlorideLurasidone Hydrochloride
    46708-497Lurasidone HydrochlorideLurasidone Hydrochloride
    46708-498Lurasidone HydrochlorideLurasidone Hydrochloride
    62332-494Lurasidone HydrochlorideLurasidone Hydrochloride
    62332-495Lurasidone HydrochlorideLurasidone Hydrochloride
    62332-496Lurasidone HydrochlorideLurasidone Hydrochloride
    62332-497Lurasidone HydrochlorideLurasidone Hydrochloride
    62332-498Lurasidone HydrochlorideLurasidone Hydrochloride
    65162-082Lurasidone HydrochlorideLurasidone Hydrochloride
    65162-879Lurasidone HydrochlorideLurasidone Hydrochloride
    65162-880Lurasidone HydrochlorideLurasidone Hydrochloride
    65162-881Lurasidone HydrochlorideLurasidone Hydrochloride
    65162-882Lurasidone HydrochlorideLurasidone Hydrochloride
    67877-638lurasidone hydrochloridelurasidone hydrochloride
    67877-639lurasidone hydrochloridelurasidone hydrochloride
    67877-640lurasidone hydrochloridelurasidone hydrochloride
    67877-641lurasidone hydrochloridelurasidone hydrochloride
    67877-642lurasidone hydrochloridelurasidone hydrochloride

    Trademark Results [Latuda]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LATUDA
    LATUDA
    77680062 3708035 Live/Registered
    SUMITOMO DAINIPPON PHARMA CO., LTD.
    2009-02-27
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.