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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6447
Application NumberANDA074145
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2015
FDA Product Classification
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