Home NDC 27241-158 Valganciclovir
Product NDC 27241-158
11-digit product format 272410158
Labeler code 27241
Product ID 27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA212234
Marketing category ANDA
Marketing start 2019-12-26
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 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 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 27241-158-60 Valganciclovir 60 in 1 BOTTLE TABLET 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-158 VALGANCICLOVIR TABLET [AJANTA PHARMA USA INC.] 7 Current NDC, Legacy NDC, 1 package rows 20220107_d13cc8ad-eaf0-4ae6-89da-a850a08b1067.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 27241-158-60 27241015860 60 TABLET in 1 BOTTLE (27241-158-60) 60 tablet 2019-12-26 0000-00-00 No No Current