NDC 0378-1190

Guanfacine

Guanfacine Hydrochloride

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

Product ID0378-1190_40f8fb73-2c25-41a6-974c-3c5bf8416516
NDC0378-1190
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1997-01-27
Marketing CategoryANDA / ANDA
Application NumberANDA074796
Labeler NameMylan Pharmaceuticals Inc.
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1190-01

100 TABLET in 1 BOTTLE (0378-1190-01)
Marketing Start Date1997-01-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1190-01 [00378119001]

Guanfacine TABLET
Marketing CategoryANDA
Application NumberANDA074796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-01-27

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:6fdcebac-0a5a-4858-b0e6-87f77ba53bf1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197746
  • 197745
  • Pharmacological Class

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

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

    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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