Home NDC 59651-444 Valganciclovir
Product NDC 59651-444
11-digit product format 596510444
Labeler code 59651
Product ID 59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir hydrochloride powder,
Dosage form FOR SOLUTION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA215124
Marketing category ANDA
Marketing start 2022-11-17
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
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 59651-444-01 Valganciclovir 1 in 1 CARTON FOR SOLUTION 1 3 59651-444-01 Valganciclovir 100 mL in 1 BOTTLE, GLASS FOR SOLUTION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-444 VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE POWDER,) FOR SOLUTION [AUROBINDO PHARMA LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20240529_1e08a87f-624a-4993-a773-8c660c27b6af.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59651-444-01 59651044401 1 BOTTLE, GLASS in 1 CARTON (59651-444-01) / 100 mL in 1 BOTTLE, GLASS 2022-11-17 0000-00-00 No No Current