Home NDC 43598-356 valganciclovir hydrochloride
Product NDC 43598-356
11-digit product format 435980356
Labeler code 43598
Product ID 43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Inc
Application ANDA206876
Marketing category ANDA
Marketing start 2017-12-12
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 A206876-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206876-001 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 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206876-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2017-12-12 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 2026-12-31 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 43598-356-30 valganciclovir hydrochloride 30 in 1 BOTTLE TABLET 30 11 43598-356-60 valganciclovir hydrochloride 60 in 1 BOTTLE TABLET 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-356 VALGANCICLOVIR HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES INC] 11 Current NDC, Legacy NDC, 2 package rows 20221224_e30ae2b2-dad2-39ba-6bc7-400807791ab0.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 · 1 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 43598-356-30 43598035630 30 TABLET in 1 BOTTLE (43598-356-30) 30 tablet 2017-12-12 0000-00-00 No No Current 43598-356-60 43598035660 60 TABLET in 1 BOTTLE (43598-356-60) 60 tablet 2017-12-12 0000-00-00 No No Current