NDC 53746-711

Guanfacine Hydrochloride

Guanfacine

Guanfacine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Guanfacine Hydrochloride.

Product ID53746-711_c4104ba1-0deb-4f9a-b2f1-2aae61271200
NDC53746-711
Product TypeHuman Prescription Drug
Proprietary NameGuanfacine Hydrochloride
Generic NameGuanfacine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-04-15
Marketing CategoryANDA /
Application NumberANDA075109
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameGUANFACINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 53746-711-01

100 TABLET in 1 BOTTLE (53746-711-01)
Marketing Start Date2022-04-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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