NDC 54766-204

PEXEVA

Paroxetine Mesylate

PEXEVA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Paroxetine Mesylate.

Product ID54766-204_7d24951f-636d-74ed-e053-2a91aa0aa29a
NDC54766-204
Product TypeHuman Prescription Drug
Proprietary NamePEXEVA
Generic NameParoxetine Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-06-02
Marketing CategoryNDA / NDA
Application NumberNDA021299
Labeler NameSebela Pharmaceuticals Inc.
Substance NamePAROXETINE MESYLATE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54766-204-01

30 TABLET, FILM COATED in 1 BOTTLE (54766-204-01)
Marketing Start Date2017-06-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-204-01 [54766020401]

PEXEVA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021299
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-02

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE MESYLATE40 mg/1

OpenFDA Data

SPL SET ID:50fe88bd-f0dd-5fad-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738523
  • 1738519
  • 1738527
  • 1738515
  • 541662
  • 541660
  • 541666
  • 541664
  • UPC Code
  • 0354766204012
  • 0354766202018
  • 0354766201011
  • 0354766203015
  • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "PEXEVA" or generic name "Paroxetine Mesylate"

    NDCBrand NameGeneric Name
    54766-201PEXEVAparoxetine mesylate
    54766-202PEXEVAparoxetine mesylate
    54766-203PEXEVAparoxetine mesylate
    54766-204PEXEVAparoxetine mesylate

    Trademark Results [PEXEVA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEXEVA
    PEXEVA
    78271367 2899689 Live/Registered
    SEBELA IRELAND LIMITED
    2003-07-08
    PEXEVA
    PEXEVA
    76615948 3033803 Live/Registered
    SEBELA IRELAND LIMITED
    2004-10-14

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