NDC 63187-302

Guanfacine

Guanfacine

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

Product ID63187-302_3dc384ee-cafe-4c56-88a3-1646beba37f9
NDC63187-302
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA074673
Labeler NameProficient Rx LP
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesCentral alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63187-302-30

30 TABLET in 1 BOTTLE (63187-302-30)
Marketing Start Date2016-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-302-30 [63187030230]

Guanfacine TABLET
Marketing CategoryANDA
Application NumberANDA074673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-02

NDC 63187-302-60 [63187030260]

Guanfacine TABLET
Marketing CategoryANDA
Application NumberANDA074673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-02

NDC 63187-302-90 [63187030290]

Guanfacine TABLET
Marketing CategoryANDA
Application NumberANDA074673
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-02

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:09442806-db7b-49de-8ffc-e4cb83138349
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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"

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