Valcyte
These highlights do not include all the information needed to use VALCYTE safely and effectively. See full prescribing information for VALCYTE. VALCYTE (valganciclovir) tablets, for oral use VALCYTE (valganciclovir) for oral solution Initial U.S. Approval: 2001
Approved
Approval ID
4c517a39-2ded-4c5a-8d56-276853414b31
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
H2-Pharma, LLC
DUNS: 028473634
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valganciclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-485
Application NumberNDA022257
Product Classification
M
Marketing Category
C73594
G
Generic Name
valganciclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2023
FDA Product Classification
INGREDIENTS (9)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: 4P3T9QF9NZ
Classification: ACTIR
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
valganciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-480
Application NumberNDA021304
Product Classification
M
Marketing Category
C73594
G
Generic Name
valganciclovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2023
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 450 mg in 1 1
Code: 4P3T9QF9NZ
Classification: ACTIR
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT