Home NDC 43598-356 valganciclovir hydrochloride
Product NDC 43598-356
11-digit product format 435980356
Labeler code 43598
Product ID 43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Inc
Application ANDA206876
Marketing category ANDA
Marketing start 2017-12-12
Substance VALGANCICLOVIR HYDROCHLORIDE
Active strength 450 mg/1
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 450 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 4P3T9QF9NZ Rxcui 313566
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-356-30 valganciclovir hydrochloride 30 in 1 BOTTLE TABLET 30 11 43598-356-60 valganciclovir hydrochloride 60 in 1 BOTTLE TABLET 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-356 VALGANCICLOVIR HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES INC] 11 Current NDC, Legacy NDC, 2 package rows 20221224_e30ae2b2-dad2-39ba-6bc7-400807791ab0.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 43598-356-30 43598035630 30 TABLET in 1 BOTTLE (43598-356-30) 30 tablet 2017-12-12 0000-00-00 No No Current 43598-356-60 43598035660 60 TABLET in 1 BOTTLE (43598-356-60) 60 tablet 2017-12-12 0000-00-00 No No Current