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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

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guanfacine - FDA Drug Approval Details