NDC 48433-124

Valganciclovir

Valganciclovir

Valganciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Safecor Health, Llc. The primary component is Valganciclovir Hydrochloride.

Product ID48433-124_1901e9dc-8b00-4756-8982-c73bfff30fa4
NDC48433-124
Product TypeHuman Prescription Drug
Proprietary NameValganciclovir
Generic NameValganciclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA203511
Labeler NameSafecor Health, LLC
Substance NameVALGANCICLOVIR HYDROCHLORIDE
Active Ingredient Strength450 mg/1
Pharm ClassesCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 48433-124-10

1 BLISTER PACK in 1 BOX (48433-124-10) > 100 TABLET, FILM COATED in 1 BLISTER PACK (48433-124-01)
Marketing Start Date2019-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48433-124-10 [48433012410]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

NDC 48433-124-01 [48433012401]

Valganciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203511
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

Drug Details

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

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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