NDC 16714-866

Paliperidone

Paliperidone

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

Product ID16714-866_bdbef4e7-07fa-40dc-9a5f-f679959ee333
NDC16714-866
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA205618
Labeler NameNorthStar RxLLC
Substance NamePALIPERIDONE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16714-866-01

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-866-01)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-866-01 [16714086601]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-15

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE1.5 mg/1

OpenFDA Data

SPL SET ID:5589ec69-c49c-44a7-9561-bbffeb918d1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866103
  • 672567
  • 672571
  • 672569
  • 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

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