Intuniv
These highlights do not include all the information needed to use INTUNIV safely and effectively. See full prescribing information for INTUNIV. INTUNIV (guanfacine) extended-release tablets, for oral useInitial U.S. Approval: 1986
Approved
Approval ID
b972af81-3a37-40be-9fe1-3ddf59852528
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
guanfacine
PRODUCT DETAILS
NDC Product Code54092-517
Application NumberNDA022037
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 1, 2020
Generic Nameguanfacine
INGREDIENTS (9)
GUANFACINE HYDROCHLORIDEActive
Quantity: 3 mg in 1 1
Code: PML56A160O
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
guanfacine
PRODUCT DETAILS
NDC Product Code54092-515
Application NumberNDA022037
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 1, 2020
Generic Nameguanfacine
INGREDIENTS (9)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: PML56A160O
Classification: ACTIM
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
guanfacine
PRODUCT DETAILS
NDC Product Code54092-513
Application NumberNDA022037
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 1, 2020
Generic Nameguanfacine
INGREDIENTS (9)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GUANFACINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: PML56A160O
Classification: ACTIM
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
guanfacine
PRODUCT DETAILS
NDC Product Code54092-519
Application NumberNDA022037
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 1, 2020
Generic Nameguanfacine
INGREDIENTS (9)
GUANFACINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: PML56A160O
Classification: ACTIM
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
guanfacine
PRODUCT DETAILS
NDC Product Code54092-520
Application NumberNDA022037
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateAugust 1, 2020
Generic Nameguanfacine