NDC 60505-3927

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 Apotex Corp.. The primary component is Guanfacine Hydrochloride.

Product ID60505-3927_00590db6-220d-df04-abf4-2360601972c6
NDC60505-3927
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine extended-release
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA205430
Labeler NameApotex Corp.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-3927-1

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3927-1)
Marketing Start Date2018-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-3927-1 [60505392701]

Guanfacine extended-release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205430
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-03

NDC 60505-3927-3 [60505392703]

Guanfacine extended-release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-03

NDC 60505-3927-8 [60505392708]

Guanfacine extended-release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-03

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:1c492e87-3406-ddb8-aaf2-e609c2ded503
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013
    • UPC Code
  • 0360505393015

    • Pharmacological Class

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

    Medicade Reported Pricing

    60505392701 GUANFACINE HCL ER 1 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.