NDC 0228-2853

guanfacine

Guanfacine

guanfacine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Guanfacine Hydrochloride.

Product ID0228-2853_0acef256-ef6e-44ba-b4ce-eaef65add36f
NDC0228-2853
Product TypeHuman Prescription Drug
Proprietary Nameguanfacine
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA200881
Labeler NameActavis Pharma, 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 Through2021-12-31

Packaging

NDC 0228-2853-11

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2853-11)
Marketing Start Date2014-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0228-2853-11 [00228285311]

guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200881
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-01

NDC 0228-2853-50 [00228285350]

guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200881
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-01
Marketing End Date2014-12-01

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:3a171942-37af-430d-8b9d-bb678ca2be4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013
  • UPC Code
  • 0302282850114
  • 0302282855119
  • 0302282853115
  • 0302282851111
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-5960GuanfacineGuanfacine
    0093-5961GuanfacineGuanfacine
    0093-5963GuanfacineGuanfacine
    0093-5964GuanfacineGuanfacine
    0228-2850guanfacineguanfacine
    0228-2851guanfacineguanfacine
    0228-2853guanfacineguanfacine
    0228-2855guanfacineguanfacine
    68151-0623GuanfacineGuanfacine
    0591-0453GuanfacineGuanfacine
    0591-0444GuanfacineGuanfacine
    70518-0268GuanfacineGuanfacine
    70518-1369GuanfacineGuanfacine
    70518-1371GuanfacineGuanfacine
    70518-0790GuanfacineGuanfacine
    24658-730GuanfacineGuanfacine
    24658-731GuanfacineGuanfacine
    42291-325guanfacineguanfacine
    42291-327guanfacineguanfacine
    42291-324guanfacineguanfacine
    42291-326guanfacineguanfacine
    60429-862GuanfacineGuanfacine
    60429-861GuanfacineGuanfacine
    63304-927GuanfacineGuanfacine
    63187-302GuanfacineGuanfacine
    0378-1190GuanfacineGuanfacine
    63304-924GuanfacineGuanfacine
    63304-926GuanfacineGuanfacine
    63304-925GuanfacineGuanfacine
    0378-1160GuanfacineGuanfacine
    63629-7138guanfacineguanfacine
    42806-048GuanfacineGuanfacine
    42806-296GuanfacineGuanfacine

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