NDC 68151-5041

Paliperidone

Paliperidone

Paliperidone is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Paliperidone.

Product ID68151-5041_5c9b883b-0ac6-4203-87d3-56bd18cdf42a
NDC68151-5041
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-09-24
Marketing CategoryANDA / ANDA
Application NumberANDA202645
Labeler NameCarilion Materials Management
Substance NamePALIPERIDONE
Active Ingredient Strength6 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-5041-8

1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68151-5041-8)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-5041-8 [68151504108]

Paliperidone TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE6 mg/1

OpenFDA Data

SPL SET ID:94e12b70-fe83-4b2d-86b0-19d830386303
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 672569
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Paliperidone" or generic name "Paliperidone"

    NDCBrand NameGeneric Name
    0378-3978Paliperidonepaliperidone
    0378-3979Paliperidonepaliperidone
    0378-3980Paliperidonepaliperidone
    0378-3981Paliperidonepaliperidone
    0591-3692PaliperidonePaliperidone
    0591-3693PaliperidonePaliperidone
    0591-3694PaliperidonePaliperidone
    0591-3695PaliperidonePaliperidone
    0904-6935PaliperidonePaliperidone
    0904-6936PaliperidonePaliperidone
    0904-6937PaliperidonePaliperidone
    10147-0951Paliperidonepaliperidone
    10147-0952Paliperidonepaliperidone
    10147-0953Paliperidonepaliperidone
    68151-5041PaliperidonePaliperidone
    70518-0850PaliperidonePaliperidone
    10147-0954PaliperidonePaliperidone
    16714-867PaliperidonePaliperidone
    16714-869PaliperidonePaliperidone
    16714-866PaliperidonePaliperidone
    16714-868PaliperidonePaliperidone
    42292-026PaliperidonePaliperidone
    42292-027PaliperidonePaliperidone
    47335-767PaliperidonePaliperidone
    47335-766PaliperidonePaliperidone
    47335-765PaliperidonePaliperidone
    47335-744PaliperidonePaliperidone
    70518-2034PaliperidonePaliperidone
    70518-2197PaliperidonePaliperidone
    65162-280PaliperidonePaliperidone
    65162-281PaliperidonePaliperidone
    65162-282PaliperidonePaliperidone
    65162-283PaliperidonePaliperidone
    49252-033PALIPERIDONEPALIPERIDONE
    49252-035PALIPERIDONEPALIPERIDONE
    49252-034PALIPERIDONEPALIPERIDONE
    49252-032PALIPERIDONEPALIPERIDONE
    60687-459PaliperidonePaliperidone
    60687-470PaliperidonePaliperidone
    43975-350PALIPERIDONEPALIPERIDONE
    43975-352PALIPERIDONEPALIPERIDONE
    43975-349PALIPERIDONEPALIPERIDONE
    43975-351PALIPERIDONEPALIPERIDONE
    42292-055PaliperidonePaliperidone
    70518-2509PaliperidonePaliperidone

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