NDC 59651-444

Valganciclovir

Valganciclovir Hydrochloride Powder,

Valganciclovir is a Oral For Solution in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Valganciclovir Hydrochloride.

Product ID59651-444_1e08a87f-624a-4993-a773-8c660c27b6af
NDC59651-444
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir Hydrochloride Powder,
Dosage FormFor Solution
Route of AdministrationORAL
Marketing Start Date2022-11-17
Marketing CategoryANDA /
Application NumberANDA215124
Labeler NameAurobindo Pharma Limited
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59651-444-01

1 BOTTLE, GLASS in 1 CARTON (59651-444-01) > 100 mL in 1 BOTTLE, GLASS
Marketing Start Date2022-11-17
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Valganciclovir" or generic name "Valganciclovir Hydrochloride Powder,"

NDCBrand NameGeneric Name
0603-6330ValganciclovirValganciclovir hydrochloride
0904-6796ValganciclovirValganciclovir
16714-765ValganciclovirValganciclovir
27241-158ValganciclovirValganciclovir
31722-832ValganciclovirValganciclovir
31722-837VALGANCICLOVIRVALGANCICLOVIR HYDROCHLORIDE
42291-875ValganciclovirValganciclovir hydrochloride
48433-124ValganciclovirValganciclovir
50268-787ValganciclovirValganciclovir
55111-762ValganciclovirValganciclovir
59651-444ValganciclovirValganciclovir hydrochloride powder,
60429-846ValganciclovirValganciclovir
63629-2288ValganciclovirValganciclovir hydrochloride
63739-076ValganciclovirValganciclovir
64380-153ValganciclovirValganciclovir hydrochloride
68084-965ValganciclovirValganciclovir
69097-277ValganciclovirValganciclovir
0004-0038Valcytevalganciclovir

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