Home NDC 0004-0039 Valcyte
Product NDC 0004-0039
11-digit product format 000040039
Labeler code 0004
Product ID 0004-0039_80c62d56-ae54-45a5-8121-16ef65a9bc48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Genentech, Inc.
Application NDA022257
Marketing category NDA
Marketing start 2009-08-28
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0004-0039 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0004-0039 0004-0039-09 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded valganciclovir hydrochloride ACTIVE INGREDIENT 4P3T9QF9NZ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ganciclovir ACTIVE MOIETY P9G3CKZ4P5 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ACACIA INACTIVE INGREDIENT 5C5403N26O VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 crospovidone INACTIVE INGREDIENT 68401960MK VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 fumaric acid INACTIVE INGREDIENT 88XHZ13131 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 mannitol INACTIVE INGREDIENT 3OWL53L36A VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 povidone K29/32 INACTIVE INGREDIENT 390RMW2PEQ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 povidone k30 INACTIVE INGREDIENT U725QWY32X VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0039 VALCYTE (VALGANCICLOVIR) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 23 Legacy NDC 20241120_dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valcyte VALGANCICLOVIR H2-Pharma, LLC 4c517a39-2ded-4c5a-8d56-276853414b31 2025-12-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022257 application number: NDA022257
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0004-0039-09 00004003909 1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) > 100 mL in 1 BOTTLE, GLASS 2009-08-28 0000-00-00 No No Current