NDC 0378-3978

Paliperidone

Paliperidone

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

Product ID0378-3978_222509f8-7c2a-404d-b942-e876b7c636ee
NDC0378-3978
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-09-24
Marketing End Date2023-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA203802
Labeler NameMylan Pharmaceuticals Inc.
Substance NamePALIPERIDONE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-3978-93

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3978-93)
Marketing Start Date2015-09-24
Marketing End Date2023-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3978-93 [00378397893]

Paliperidone TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-24

NDC 0378-3978-77 [00378397877]

Paliperidone TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-24
Marketing End Date2016-07-15

NDC 0378-3978-05 [00378397805]

Paliperidone TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-24
Marketing End Date2016-07-15

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE1.5 mg/1

OpenFDA Data

SPL SET ID:74702340-19bf-467e-80cd-68dca9d374d2
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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