NDC 54092-517

Intuniv

Guanfacine

Intuniv is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Guanfacine Hydrochloride.

Product ID54092-517_1eef54c1-5c87-44f1-bab6-42f72d4fe0be
NDC54092-517
Product TypeHuman Prescription Drug
Proprietary NameIntuniv
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-09-02
Marketing CategoryNDA / NDA
Application NumberNDA022037
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 54092-517-02

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-517-02)
Marketing Start Date2009-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-517-03 [54092051703]

Intuniv TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-02

NDC 54092-517-02 [54092051702]

Intuniv TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022037
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-02

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:b972af81-3a37-40be-9fe1-3ddf59852528
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862019
  • 862006
  • 862021
  • 862010
  • 862013
  • 862025
  • 862015
  • 862027
  • 1092566
  • 1092567
  • UPC Code
  • 0354092513024
  • 0354092519026
  • 0354092515028
  • Pharmacological Class

    • Central alpha-2 Adrenergic Agonist [EPC]
    • Adrenergic alpha2-Agonists [MoA]

    Medicade Reported Pricing

    54092051702 INTUNIV ER 3 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Intuniv" or generic name "Guanfacine"

    NDCBrand NameGeneric Name
    54092-520IntunivIntuniv
    54092-513IntunivIntuniv
    54092-517IntunivIntuniv
    54092-515IntunivIntuniv
    54092-519IntunivIntuniv
    64725-0513IntunivIntuniv
    64725-0515IntunivIntuniv
    0093-5960GuanfacineGuanfacine
    0093-5961GuanfacineGuanfacine
    0093-5963GuanfacineGuanfacine
    0093-5964GuanfacineGuanfacine
    0228-2850guanfacineguanfacine
    0228-2851guanfacineguanfacine
    0228-2853guanfacineguanfacine
    0228-2855guanfacineguanfacine

    Trademark Results [Intuniv]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INTUNIV
    INTUNIV
    78649257 not registered Dead/Abandoned
    Shire LLC
    2005-06-13
    INTUNIV
    INTUNIV
    77754292 3877676 Dead/Cancelled
    Shire LLC
    2009-06-08
    INTUNIV
    INTUNIV
    77754273 3877675 Dead/Cancelled
    Shire LLC
    2009-06-08
    INTUNIV
    INTUNIV
    77674806 3871096 Live/Registered
    Shire LLC
    2009-02-20

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