Home NDC 0904-6796 Valganciclovir
Product NDC 0904-6796
11-digit product format 009046796
Labeler code 0904
Product ID 0904-6796_d77110cf-ef90-4565-a751-8ebedc10c2aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA205166
Marketing category ANDA
Marketing start 2016-03-18
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 2027-12-31
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 A205166-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205166-001 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 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205166-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 0904-6796-04 Valganciclovir 30 in 1 CARTON TABLET, FILM COATED 30 6 0904-6796-04 Valganciclovir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 0904-6796-10 Valganciclovir 20 in 1 CARTON TABLET, FILM COATED 20 6 0904-6796-10 Valganciclovir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6796 VALGANCICLOVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 4 package rows 20250313_6a6533fd-0579-4059-ba87-aa399829a8b0.zip
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.
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 0904-6796-04 00904679604 30 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2016-03-18 0000-00-00 No No Current 0904-6796-10 00904679610 20 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK 20 blister pack 2016-03-18 0000-00-00 No No Current