NDC 70518-0793

Guanfacine Hydrochloride

Guanfacine

Guanfacine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Guanfacine Hydrochloride.

Product ID70518-0793_5bc403c9-f121-60d8-e053-2a91aa0aa656
NDC70518-0793
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Hydrochloride
Generic NameGuanfacine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-10-17
Marketing CategoryANDA / ANDA
Application NumberANDA075109
Labeler NameREMEDYREPACK INC.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0793-0

30 TABLET in 1 BLISTER PACK (70518-0793-0)
Marketing Start Date2017-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0793-0 [70518079300]

Guanfacine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-17
Marketing End Date2020-05-04

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:fc86633a-ee61-4f16-82d4-765539a52d7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197746

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68084-748Guanfacine HydrochlorideGuanfacine Hydrochloride
    70518-0793Guanfacine HydrochlorideGuanfacine Hydrochloride
    17856-0711Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-310Guanfacine HydrochlorideGuanfacine Hydrochloride
    42291-311Guanfacine HydrochlorideGuanfacine Hydrochloride
    50090-4119Guanfacine HydrochlorideGuanfacine Hydrochloride
    50268-373Guanfacine HydrochlorideGuanfacine Hydrochloride
    50268-374Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1065Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1062Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1061Guanfacine HydrochlorideGuanfacine Hydrochloride
    0378-1063Guanfacine HydrochlorideGuanfacine Hydrochloride
    64725-0711Guanfacine HydrochlorideGuanfacine Hydrochloride
    65162-713Guanfacine HydrochlorideGuanfacine Hydrochloride
    65162-711Guanfacine HydrochlorideGuanfacine Hydrochloride
    0093-5960GuanfacineGuanfacine
    0093-5961GuanfacineGuanfacine
    0093-5963GuanfacineGuanfacine
    0093-5964GuanfacineGuanfacine
    0228-2850guanfacineguanfacine
    0228-2851guanfacineguanfacine
    0228-2853guanfacineguanfacine
    0228-2855guanfacineguanfacine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.