NDC 65162-281

Paliperidone

Paliperidone

Paliperidone is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Paliperidone.

Product ID65162-281_03186c75-888e-4da5-aec9-4a649b0b9e5d
NDC65162-281
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-09-24
Marketing CategoryANDA / ANDA
Application NumberANDA204707
Labeler NameAmneal Pharmaceuticals LLC
Substance NamePALIPERIDONE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65162-281-03

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-03)
Marketing Start Date2019-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-281-03 [65162028103]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204707
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-24

NDC 65162-281-09 [65162028109]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204707
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE3 mg/1

OpenFDA Data

SPL SET ID:7b269778-803b-4ce2-a8c0-636fb131d16a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866103
  • 672567
  • 672571
  • 672569
  • UPC Code
  • 0365162280036
  • 0365162281033
  • 0365162283037
  • 0365162282030
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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.