Home NDC 68084-965 Valganciclovir
Product NDC 68084-965
11-digit product format 680840965
Labeler code 68084
Product ID 68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA203511
Marketing category ANDA
Marketing start 2015-01-07
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
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 68084-965-18 Valganciclovir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 68084-965-19 Valganciclovir 20 in 1 CARTON TABLET, FILM COATED 20 7 68084-965-25 Valganciclovir 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 7 68084-965-95 Valganciclovir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALGANCICLOVIR HYDROCHLORIDE ACTIVE INGREDIENT 4P3T9QF9NZ VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 Ganciclovir ACTIVE MOIETY P9G3CKZ4P5 VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 crospovidone INACTIVE INGREDIENT 68401960MK VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-965 VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 7 Current NDC, Legacy NDC, 4 package rows 20240925_4db6dd63-e56b-45a4-86b2-ee125a1854a0.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 68084-965-18 68084096518 1 in 1 BLISTER PACK Historical 68084-965-19 68084096519 20 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18) 20 blister pack 2024-09-22 No No Current 68084-965-25 68084096525 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95) 30 blister pack 2015-01-16 0000-00-00 No No Current 68084-965-95 68084096595 1 in 1 BLISTER PACK Historical