NDC 0781-5456

Guanfacine Extended-Release

Guanfacine

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

Product ID0781-5456_0cfcbe23-6e40-4f59-859b-bce2a8db1881
NDC0781-5456
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Extended-Release
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-06-03
Marketing End Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA202568
Labeler NameSandoz Inc
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0781-5456-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5456-01)
Marketing Start Date2015-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5456-01 [00781545601]

Guanfacine Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202568
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-03
Marketing End Date2019-11-30

NDC 0781-5456-31 [00781545631]

Guanfacine Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202568
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-03
Marketing End Date2018-10-04

NDC 0781-5456-13 [00781545613]

Guanfacine Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202568
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-03
Marketing End Date2018-10-04

NDC 0781-5456-10 [00781545610]

Guanfacine Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202568
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-03
Marketing End Date2018-10-04

NDC 0781-5456-06 [00781545606]

Guanfacine Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202568
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-03
Marketing End Date2018-10-04

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:b0ea8a87-f0b7-4bdb-bd80-c1c40d5a213d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Guanfacine Extended-Release" or generic name "Guanfacine"

    NDCBrand NameGeneric Name
    0781-5456Guanfacine Extended-ReleaseGuanfacine Extended-Release
    0781-5451Guanfacine Extended-ReleaseGuanfacine Extended-Release
    0781-5457Guanfacine Extended-ReleaseGuanfacine Extended-Release
    0781-5452Guanfacine Extended-ReleaseGuanfacine Extended-Release
    24979-538Guanfacine Extended-ReleaseGuanfacine Extended-Release
    24979-534Guanfacine Extended-ReleaseGuanfacine Extended-Release
    24979-533Guanfacine Extended-ReleaseGuanfacine Extended-Release
    24979-536Guanfacine Extended-ReleaseGuanfacine Extended-Release
    60429-963Guanfacine Extended-ReleaseGuanfacine Extended-Release
    60429-960Guanfacine Extended-ReleaseGuanfacine Extended-Release
    60505-3930Guanfacine extended-releaseGuanfacine extended-release
    60505-3927Guanfacine extended-releaseGuanfacine extended-release
    60429-961Guanfacine Extended-ReleaseGuanfacine Extended-Release
    60429-962Guanfacine Extended-ReleaseGuanfacine Extended-Release
    60505-3929Guanfacine extended-releaseGuanfacine extended-release
    60505-3928Guanfacine extended-releaseGuanfacine extended-release
    70518-2771Guanfacine Extended-ReleaseGuanfacine Extended-Release
    71205-944Guanfacine Extended-ReleaseGuanfacine Extended-Release
    71205-946Guanfacine Extended-ReleaseGuanfacine Extended-Release
    71205-947Guanfacine Extended-ReleaseGuanfacine Extended-Release
    71205-945Guanfacine Extended-ReleaseGuanfacine Extended-Release
    0093-5960GuanfacineGuanfacine
    0093-5961GuanfacineGuanfacine
    0093-5963GuanfacineGuanfacine
    0093-5964GuanfacineGuanfacine
    0228-2850guanfacineguanfacine
    0228-2851guanfacineguanfacine
    0228-2853guanfacineguanfacine
    0228-2855guanfacineguanfacine
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