NDC 50268-373

Guanfacine Hydrochloride

Guanfacine

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

Product ID50268-373_76dd1d5b-cad9-7cb7-e053-2a91aa0a7695
NDC50268-373
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Hydrochloride
Generic NameGuanfacine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA075109
Labeler NameAvPAK
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50268-373-15

50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-373-15) > 1 TABLET in 1 BLISTER PACK (50268-373-11)
Marketing Start Date2018-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-373-15 [50268037315]

Guanfacine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-27
Marketing End Date2019-09-30

NDC 50268-373-11 [50268037311]

Guanfacine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075109
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-27
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:cc3cc6de-583c-4180-9f4c-9e4c75eb6f38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197746
  • 197745

    • 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
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