NDC 63304-925

Guanfacine

Guanfacine

Guanfacine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc. The primary component is Guanfacine Hydrochloride.

Product ID63304-925_0dde8492-8a24-48f6-b9cf-f806166e576c
NDC63304-925
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine
Generic NameGuanfacine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA205689
Labeler NameSun Pharmaceutical Industries, 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 Through2021-12-31

Packaging

NDC 63304-925-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-925-01)
Marketing Start Date2018-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-925-30 [63304092530]

Guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205689
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17

NDC 63304-925-05 [63304092505]

Guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205689
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-17

NDC 63304-925-01 [63304092501]

Guanfacine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205689
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-17

Drug Details

Active Ingredients

IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:2d0a0f8e-5098-4ee2-a4ee-d026789923e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 862006
  • 862019
  • 862025
  • 862013
  • UPC Code
  • 0363304926019
  • 0363304927016
  • Pharmacological Class

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

    Medicade Reported Pricing

    63304092501 GUANFACINE HCL ER 2 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.