Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
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
68084-965Application Number
ANDA203511Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 14, 2022CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ValganciclovirActive
Code: 4P3T9QF9NZClass: ACTIRQuantity: 450 mg in 1 1