Guanfacine
Revised: April 2014 2000647-01
Approved
Approval ID
c6e30fc7-5ad3-41c1-a673-b4db53f2b98f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2015
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
PRODUCT DETAILS
NDC Product Code54868-6447
Application NumberANDA074145
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 15, 2015
Generic NameGuanfacine
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: PML56A160O
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT