Home NDC 0591-2579 Valganciclovir hydrochloride for Oral
Product NDC 0591-2579
11-digit product format 005912579
Labeler code 0591
Product ID 0591-2579_51bfc674-3cf7-4d5d-9ca8-b7863b2e49b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA205220
Marketing category ANDA
Marketing start 2016-08-26
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 0591-2579-20 Valganciclovir hydrochloride for Oral 100 mL in 1 BOTTLE, GLASS POWDER, FOR SOLUTION 100 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2579 VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.] 23 Current NDC, Legacy NDC, 1 package rows 20230331_92281301-5fb5-4eea-8766-4863e241c234.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-2579-20 00591257920 100 mL in 1 BOTTLE, GLASS (0591-2579-20) 100 ml 2016-08-26 0000-00-00 No No Current