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-RELEASE TABLETS. GUANFACINE extended-release tablets, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
07a701e2-39b7-4bb1-a7c7-d9baed4ab18a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code24979-534
Application NumberANDA201408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2017
FDA Product Classification
INGREDIENTS (11)
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
GUANFACINEActive
Quantity: 2 mg in 1 1
Code: 30OMY4G3MK
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-536
Application NumberANDA201408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2017
FDA Product Classification
INGREDIENTS (12)
GUANFACINEActive
Quantity: 3 mg in 1 1
Code: 30OMY4G3MK
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
Guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-533
Application NumberANDA201408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2017
FDA Product Classification
INGREDIENTS (11)
GUANFACINEActive
Quantity: 1 mg in 1 1
Code: 30OMY4G3MK
Classification: ACTIB
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Guanfacine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-538
Application NumberANDA201408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2017
FDA Product Classification
INGREDIENTS (12)
GUANFACINEActive
Quantity: 4 mg in 1 1
Code: 30OMY4G3MK
Classification: ACTIB
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT