NDC 42291-310

Guanfacine Hydrochloride

Guanfacine Hydrochloride

Guanfacine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Guanfacine Hydrochloride.

Product ID42291-310_78d8920c-2afc-386a-e053-2991aa0a2d73
NDC42291-310
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Hydrochloride
Generic NameGuanfacine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-03-03
Marketing CategoryANDA / ANDA
Application NumberANDA075109
Labeler NameAvKARE, Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-310-90

90 TABLET in 1 BOTTLE (42291-310-90)
Marketing Start Date2011-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-310-90 [42291031090]

Guanfacine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-03-03

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:7332ea0c-a7ff-cca0-4c47-39c721b47edd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197746
  • 197745
    • UPC Code
  • 0342291310902
  • 0342291311909

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-1061Guanfacine Hydrochlorideguanfacine
    0378-1062Guanfacine Hydrochlorideguanfacine
    0378-1063Guanfacine Hydrochlorideguanfacine
    0378-1065Guanfacine Hydrochlorideguanfacine
    17856-0711Guanfacine HydrochlorideGuanfacine
    29300-458Guanfacine HydrochlorideGuanfacine Hydrochloride
    29300-459Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-310Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-311Guanfacine HydrochlorideGuanfacine Hydrochloride
    50090-4119Guanfacine HydrochlorideGuanfacine
    50090-6073Guanfacine HydrochlorideGuanfacine
    50268-373Guanfacine HydrochlorideGuanfacine
    50268-374Guanfacine HydrochlorideGuanfacine
    53746-711Guanfacine HydrochlorideGuanfacine
    53746-713Guanfacine HydrochlorideGuanfacine
    60687-710Guanfacine HydrochlorideGuanfacine Hydrochloride
    64725-0711Guanfacine HydrochlorideGuanfacine Hydrochloride
    65162-711Guanfacine HydrochlorideGuanfacine
    65162-713Guanfacine HydrochlorideGuanfacine
    68071-2719Guanfacine HydrochlorideGuanfacine Hydrochloride
    68084-748Guanfacine HydrochlorideGuanfacine Hydrochloride
    70518-0793Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1160Guanfacineguanfacine Hydrochloride
    0378-1190Guanfacineguanfacine Hydrochloride
    60429-861Guanfacineguanfacine Hydrochloride
    60429-862Guanfacineguanfacine Hydrochloride
    70518-0268Guanfacineguanfacine Hydrochloride
    67857-705TENEXguanfacine hydrochloride
    67857-706TENEXguanfacine hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.