guanfacine
These highlights do not include all the information needed to use GUANFACINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GUANFACINE EXTENDED-RELEAS E TABLETS . GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
3a171942-37af-430d-8b9d-bb678ca2be4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2020
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 4
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 Code0228-2855
Application NumberANDA200881
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: PML56A160O
Classification: ACTIM
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2853
Application NumberANDA200881
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (11)
GUANFACINE HYDROCHLORIDEActive
Quantity: 3 mg in 1 1
Code: PML56A160O
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2850
Application NumberANDA200881
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: PML56A160O
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0228-2851
Application NumberANDA200881
Product Classification
M
Marketing Category
C73584
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2022
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: PML56A160O
Classification: ACTIM
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT