Home NDC 31722-837 VALGANCICLOVIR
Product NDC 31722-837
11-digit product format 317220837
Labeler code 31722
Product ID 31722-837_eaad537e-d8e5-24a2-e053-2a95a90ad075
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALGANCICLOVIR HYDROCHLORIDE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA211475
Marketing category ANDA
Marketing start 2022-10-04
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 31722-837-10 VALGANCICLOVIR 1 in 1 CARTON POWDER, FOR SOLUTION 1 1 31722-837-10 VALGANCICLOVIR 100 mL in 1 BOTTLE, GLASS POWDER, FOR SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-837 VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20221011_28703782-9f48-4866-a32d-1604da9dee6b.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 31722-837-10 31722083710 1 BOTTLE, GLASS in 1 CARTON (31722-837-10) / 100 mL in 1 BOTTLE, GLASS 2022-10-04 0000-00-00 No No Current