Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Legacy Pharmaceutical Packaging, LLC
McKesson Corporation DBA SKY Packaging
143213275
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valganciclovir
Product Details
NDC Product Code
63739-076Application Number
ANDA205166Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 8, 2023CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 450 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT