Home NDC 42291-972 Valganciclovir hydrochloride for Oral
Product NDC 42291-972
11-digit product format 422910972
Labeler code 42291
Product ID 42291-972_48c2d3e0-cf43-2438-e063-6294a90a9557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler AvKARE
Application ANDA205220
Marketing category ANDA
Marketing start 2023-10-17
Substance VALGANCICLOVIR HYDROCHLORIDE
Active strength 50 mg/mL
Pharmacologic classes Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Valganciclovir hydrochloride for Oral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii 4P3T9QF9NZ Rxcui 863559
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-972-01 Valganciclovir hydrochloride for Oral 100 mL in 1 BOTTLE POWDER, FOR SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-972 VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [AVKARE] 1 Current NDC, 1 package rows 20231018_07eb5abf-2322-4fb9-e063-6394a90a2311.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-972-01 42291097201 100 mL in 1 BOTTLE (42291-972-01) 100 ml 2023-10-17 No No Historical