Home NDC 42291-972 Valganciclovir hydrochloride for Oral
Product NDC 42291-972
11-digit product format 422910972
Labeler code 42291
Product ID 42291-972_48c2d3e0-cf43-2438-e063-6294a90a9557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler AvKARE
Application ANDA205220
Marketing category ANDA
Marketing start 2023-10-17
Substance VALGANCICLOVIR HYDROCHLORIDE
Active strength 50 mg/mL
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 A205220-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205220-001 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 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205220-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2016-07-18 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 hydrochloride for Oral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL
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 863559 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 42291-972-01 Valganciclovir hydrochloride for Oral 100 mL in 1 BOTTLE POWDER, FOR SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-972 VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [AVKARE] 1 Current NDC, 1 package rows 20231018_07eb5abf-2322-4fb9-e063-6394a90a2311.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 Sample Exclude flag Status 42291-972-01 42291097201 100 mL in 1 BOTTLE (42291-972-01) 100 ml 2023-10-17 No No Current