Guanfacine extended-release
These highlights do not include all the information needed to use GUANFACINE safely and effectively. See full prescribing information for GUANFACINE . GUANFACINE Extended-Release tablets, for oral useInitial U.S. Approval: 1986
Approved
Approval ID
93a21df1-4618-4676-933d-3351231dc1bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 12, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72162-2030
Application NumberANDA205430
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2023
FDA Product Classification
INGREDIENTS (8)
GUANFACINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: PML56A160O
Classification: ACTIM
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT