Home NDC 27241-158 Valganciclovir
Product NDC 27241-158
11-digit product format 272410158
Labeler code 27241
Product ID 27241-158_f537ddb1-f868-4bef-937b-e520b04e26a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA212234
Marketing category ANDA
Marketing start 2019-12-26
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 A212234-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212234-001 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.
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 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212234-001 VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE TABLET / ORAL AB 2019-12-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 27241-158-60 Valganciclovir 60 in 1 BOTTLE TABLET 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-158 VALGANCICLOVIR TABLET [AJANTA PHARMA USA INC.] 7 Current NDC, Legacy NDC, 1 package rows 20220107_d13cc8ad-eaf0-4ae6-89da-a850a08b1067.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 27241-158-60 27241015860 60 TABLET in 1 BOTTLE (27241-158-60) 60 tablet 2019-12-26 0000-00-00 No No Current