NDC 64380-153

Valganciclovir

Valganciclovir Hydrochloride

Valganciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Valganciclovir Hydrochloride.

Product ID64380-153_65b7d0a6-97c0-43f8-a39d-8f29a9d154af
NDC64380-153
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-09-12
Marketing CategoryANDA /
Application NumberANDA200790
Labeler NameStrides Pharma Science Limited
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength450 mg/1
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 64380-153-01

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-153-01)
Marketing Start Date2022-09-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0603-6330ValganciclovirValganciclovir hydrochloride
0904-6796ValganciclovirValganciclovir
16714-765ValganciclovirValganciclovir
27241-158ValganciclovirValganciclovir
31722-832ValganciclovirValganciclovir
42291-875ValganciclovirValganciclovir hydrochloride
48433-124ValganciclovirValganciclovir
50268-787ValganciclovirValganciclovir
55111-762ValganciclovirValganciclovir
68084-965ValganciclovirValganciclovir
69097-277ValganciclovirValganciclovir
60429-846ValganciclovirValganciclovir
0004-0038Valcytevalganciclovir
0004-0039Valcytevalganciclovir hydrochloride
27241-159Valganciclovir hydrochlorideValganciclovir hydrochloride
43598-356valganciclovir hydrochloridevalganciclovir hydrochloride
0591-2579Valganciclovir hydrochloride for OralValganciclovir hydrochloride

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