NDC 70518-1369

Guanfacine

Guanfacine

Guanfacine 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 ID70518-1369_73209722-6e16-ee00-e053-2991aa0a1ee3
NDC70518-1369
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA074145
Labeler NameREMEDYREPACK INC.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1369-0

30 TABLET in 1 BLISTER PACK (70518-1369-0)
Marketing Start Date2018-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1369-0 [70518136900]

Guanfacine TABLET
Marketing CategoryANDA
Application NumberANDA074145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-10

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:b6b1d427-e19a-4fc1-b518-f58bacc46736
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197745
  • 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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