Home NDC 61269-485 Valcyte
Product NDC 61269-485
11-digit product format 612690485
Labeler code 61269
Product ID 61269-485_c70cbfa5-6b69-4fd4-8ad0-e819c8795746
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler H2-Pharma, LLC
Application NDA022257
Marketing category NDA
Marketing start 2009-08-28
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 61269-485 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61269-485 61269-485-10 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N022257-001 VALCYTE VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022257-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022257-001 8889109 2027-12-11 Drug product 2017-10-16 N022257-001 9642911 2027-12-11 Drug product 2017-06-02
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 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Valcyte
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284587 Internal RxNorm lookup 313566 Internal RxNorm lookup 863559 Internal RxNorm lookup 863562 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 61269-485-10 Valcyte 100 mL in 1 BOTTLE, GLASS POWDER, FOR SOLUTION 100 24 61269-485-10 Valcyte 1 in 1 CARTON POWDER, FOR SOLUTION 1 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-485 VALCYTE (VALGANCICLOVIR) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [H2-PHARMA, LLC] 23 Current NDC, 2 package rows 20250112_4c517a39-2ded-4c5a-8d56-276853414b31.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 Marketing start Sample Exclude flag Status 61269-485-10 61269048510 1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS 2009-08-28 No No Current