Home NDC 72205-019 valganciclovir hydrochloride
Product NDC 72205-019
11-digit product format 722050019
Labeler code 72205
Product ID 72205-019_614ff447-7e5f-4ea6-ba85-ec1f6497b360
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form FOR SOLUTION
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA210169
Marketing category ANDA
Marketing start 2022-02-17
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base valganciclovir hydrochloride
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 72205-019-01 valganciclovir hydrochloride 1 in 1 CARTON FOR SOLUTION 1 1 72205-019-01 valganciclovir hydrochloride 100 mL in 1 BOTTLE FOR SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-019 VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, Legacy NDC, 2 package rows 20220916_614ff447-7e5f-4ea6-ba85-ec1f6497b360.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 72205-019-01 72205001901 1 BOTTLE in 1 CARTON (72205-019-01) / 100 mL in 1 BOTTLE 1 bottle 2022-09-14 0000-00-00 No No Current