Home NDC 65862-753 VALGANCICLOVIR HYDROCHLORIDE
Product NDC 65862-753
11-digit product format 658620753
Labeler code 65862
Product ID 65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALGANCICLOVIR HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA204750
Marketing category ANDA
Marketing start 2016-03-31
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 A204750-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204750-001 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 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204750-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2016-03-31 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 HYDROCHLORIDE
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 65862-753-01 VALGANCICLOVIR HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 12 65862-753-05 VALGANCICLOVIR HYDROCHLORIDE 500 in 1 BOTTLE TABLET 500 12 65862-753-18 VALGANCICLOVIR HYDROCHLORIDE 180 in 1 BOTTLE TABLET 180 12 65862-753-60 VALGANCICLOVIR HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 12 65862-753-99 VALGANCICLOVIR HYDROCHLORIDE 1000 in 1 BOTTLE TABLET 1000 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-753 VALGANCICLOVIR HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] 11 Current NDC, Legacy NDC, 5 package rows 20240529_8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83.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 · 2 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 65862-753-01 65862075301 100 TABLET in 1 BOTTLE (65862-753-01) 100 tablet 2016-03-31 0000-00-00 No No Current 65862-753-05 65862075305 500 TABLET in 1 BOTTLE (65862-753-05) 500 tablet 2016-03-31 0000-00-00 No No Current 65862-753-18 65862075318 180 TABLET in 1 BOTTLE (65862-753-18) 180 tablet 2016-03-31 0000-00-00 No No Current 65862-753-60 65862075360 60 TABLET in 1 BOTTLE (65862-753-60) 60 tablet 2016-03-31 0000-00-00 No No Current 65862-753-99 65862075399 1000 TABLET in 1 BOTTLE (65862-753-99) 1000 tablet 2016-03-31 0000-00-00 No No Current