Home NDC 55111-762 Valganciclovir
Product NDC 55111-762
11-digit product format 551110762
Labeler code 55111
Product ID 55111-762_01a187d9-f0b8-d068-0be0-98654e8de135
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA203511
Marketing category ANDA
Marketing start 2014-12-15
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 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 55111-762-05 Valganciclovir 500 in 1 BOTTLE TABLET, FILM COATED 500 10 55111-762-60 Valganciclovir 60 in 1 BOTTLE TABLET, FILM COATED 60 10 55111-762-78 Valganciclovir 10 in 1 CARTON TABLET, FILM COATED 10 10 55111-762-79 Valganciclovir 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALGANCICLOVIR HYDROCHLORIDE ACTIVE INGREDIENT 4P3T9QF9NZ VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 Ganciclovir ACTIVE MOIETY P9G3CKZ4P5 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 crospovidone INACTIVE INGREDIENT 68401960MK VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 hypromellose 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 hypromellose 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 povidone K30 INACTIVE INGREDIENT U725QWY32X VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 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 55111-762 VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 10 Current NDC, Legacy NDC, 4 package rows 20220202_f37c0780-b953-46c2-d7d4-959fc2c3e571.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 55111-762-05 55111076205 500 TABLET, FILM COATED in 1 BOTTLE (55111-762-05) 2014-12-15 0000-00-00 No No Current 55111-762-60 55111076260 60 TABLET, FILM COATED in 1 BOTTLE (55111-762-60) 2014-12-15 0000-00-00 No No Current 55111-762-78 55111076278 10 BLISTER PACK in 1 CARTON (55111-762-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-762-79) 10 blister pack 2014-12-15 0000-00-00 No No Current 55111-762-79 55111076279 10 in 1 BLISTER PACK Historical