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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203511-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203511-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203511-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2014-11-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4P3T9QF9NZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313566 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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