Home NDC 71151-003 VALGANCICLOVIR
Product NDC 71151-003
11-digit product format 711510003
Labeler code 71151
Product ID 71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir
Dosage form FOR SOLUTION
Route ORAL
Labeler airis PHARMA PVT LTD
Application ANDA210169
Marketing category ANDA
Marketing start 2022-02-28
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base VALGANCICLOVIR
Listing expiration 2026-12-31 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 71151-003-01 VALGANCICLOVIR 100 mL in 1 BOTTLE, DISPENSING FOR SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71151-003 VALGANCICLOVIR FOR SOLUTION [AIRIS PHARMA PVT LTD] 1 Current NDC, Legacy NDC, 1 package rows 20220304_ddfb4e0e-64f5-4654-8670-91b8b6abe794.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 71151-003-01 71151000301 100 mL in 1 BOTTLE, DISPENSING (71151-003-01) 100 ml 2022-02-28 0000-00-00 No No Current