NDC 63629-8203

Guanfacine

Guanfacine

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

Product ID63629-8203_33103dcb-966d-427f-9283-d6767eda21d8
NDC63629-8203
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA205689
Labeler NameBryant Ranch Prepack
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-8203-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8203-1)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8203-1 [63629820301]

Guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205689
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:f070a54a-2738-4ef2-a98a-f9e7a7a56f55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862013
  • Pharmacological Class

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