NDC 64725-0515

Intuniv

Guanfacine

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

Product ID64725-0515_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb
NDC64725-0515
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 NameTYA Pharmaceuticals
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0515-1

30 TABLET, EXTENDED RELEASE in 1 CONTAINER (64725-0515-1)
Marketing Start Date2009-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0515-1 [64725051501]

Intuniv TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862015
  • 862010
  • 862013
  • Pharmacological Class

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

    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.