Guanfacine
Approved
Approval ID
fbf22eeb-27f5-46aa-be39-5aef43101369
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
guanfacine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4876
Application NumberANDA074796
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2010
FDA Product Classification
INGREDIENTS (7)
GUANFACINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: PML56A160O
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT