NDC 0378-1063

Guanfacine Hydrochloride

Guanfacine

Guanfacine Hydrochloride 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 Guanfacine Hydrochloride.

Product ID0378-1063_372956db-cf21-48e2-93de-9a7fe5a4139f
NDC0378-1063
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Hydrochloride
Generic NameGuanfacine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA202578
Labeler NameMylan Pharmaceuticals Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-1063-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1063-01)
Marketing Start Date2015-06-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1063-01 [00378106301]

Guanfacine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-02
Marketing End Date2019-04-30

NDC 0378-1063-93 [00378106393]

Guanfacine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-02
Marketing End Date2016-09-08

NDC 0378-1063-05 [00378106305]

Guanfacine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-02
Marketing End Date2016-09-08

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:2d298ebe-8f68-4055-80d7-d86f5b5e6814
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68084-748Guanfacine HydrochlorideGuanfacine Hydrochloride
    70518-0793Guanfacine HydrochlorideGuanfacine Hydrochloride
    17856-0711Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-310Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-311Guanfacine HydrochlorideGuanfacine Hydrochloride
    50090-4119Guanfacine HydrochlorideGuanfacine Hydrochloride
    50268-373Guanfacine HydrochlorideGuanfacine Hydrochloride
    50268-374Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1065Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1062Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1061Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1063Guanfacine HydrochlorideGuanfacine Hydrochloride
    64725-0711Guanfacine HydrochlorideGuanfacine Hydrochloride
    65162-713Guanfacine HydrochlorideGuanfacine Hydrochloride
    65162-711Guanfacine HydrochlorideGuanfacine Hydrochloride
    0093-5960GuanfacineGuanfacine
    0093-5961GuanfacineGuanfacine
    0093-5963GuanfacineGuanfacine
    0093-5964GuanfacineGuanfacine
    0228-2850guanfacineguanfacine
    0228-2851guanfacineguanfacine
    0228-2853guanfacineguanfacine
    0228-2855guanfacineguanfacine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.