Home NDC 0904-7419 valganciclovir hydrochloride
Product NDC 0904-7419
11-digit product format 009047419
Labeler code 0904
Product ID 0904-7419_35e1c8f8-af47-4866-b5d8-b1ce197cece0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form FOR SOLUTION
Route ORAL
Labeler MAJOR PHARMACEUTICALS
Application ANDA210169
Marketing category ANDA
Marketing start 2022-02-17
Marketing end 2026-05-30
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
Current FDA listing Yes DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7419-04 valganciclovir hydrochloride 100 mL in 1 BOTTLE FOR SOLUTION 100 2 0904-7419-04 valganciclovir hydrochloride 1 in 1 CARTON FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7419 VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20240107_f656a741-7f9c-4173-8893-c259b0d96f5b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7419-04 00904741904 1 BOTTLE in 1 CARTON (0904-7419-04) / 100 mL in 1 BOTTLE 1 bottle 2024-01-05 2026-05-30 No No Historical