TENEX
Approved
Approval ID
886e050c-dd22-4f35-ac3b-243f091125c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2013
Manufacturers
FDA
Promius Pharma, LLC
DUNS: 020408265
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
guanfacine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67857-705
Application NumberNDA019032
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2013
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: PML56A160O
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
guanfacine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67857-706
Application NumberNDA019032
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2013
FDA Product Classification
INGREDIENTS (6)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: PML56A160O
Classification: ACTIM