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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-517
Application NumberNDA022037
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-515
Application NumberNDA022037
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-513
Application NumberNDA022037
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-519
Application NumberNDA022037
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-520
Application NumberNDA022037
Product Classification
M
Marketing Category
C73594
G
Generic Name
guanfacine
Product Specifications
Effective DateAugust 1, 2020
FDA Product Classification