NDC 0093-5963

Guanfacine

Guanfacine

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

Product ID0093-5963_7af5429c-2eb3-4094-96d5-0b0853779d00
NDC0093-5963
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA201382
Labeler NameTeva Pharmaceuticals USA, 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 0093-5963-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0093-5963-01)
Marketing Start Date2015-06-02
Marketing End Date2021-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5963-01 [00093596301]

Guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-02

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:160f180e-584d-49be-8f75-7cf5ef1422f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013
    • UPC Code
  • 0300935961019
  • 0300935964010

    • 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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