valganciclovir hydrochloride

Product NDC: 0904-7419
11-digit product format: 009047419
Labeler code: 0904
Product ID: 0904-7419_35e1c8f8-af47-4866-b5d8-b1ce197cece0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valganciclovir hydrochloride
Dosage form: FOR SOLUTION
Route: ORAL
Labeler: MAJOR PHARMACEUTICALS
Application: ANDA210169
Marketing category: ANDA
Marketing start: 2022-02-17
Marketing end: 2026-05-30
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
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-7419		D	Discontinued by firm		2026-08-17
excluded package	package	0904-7419	0904-7419-04	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210169-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB		2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210169-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210169-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2022-02-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210169-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210169-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210169-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210169-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210169-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210169-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210169-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210169-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210169-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210169-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210169-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210169-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210169-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210169-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210169-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210169-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210169-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210169-001	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210169-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210169-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210169-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210169-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210169-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210169-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210169-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210169-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210169-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210169-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210169-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210169-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210169-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210169-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86	Product name	9	20221206
9f9c8b60-edb9-4f29-9472-12fa266e8ead	Product name	5	20190912
db601a58-ade5-4a08-a9d0-73d4222e8e5a	Product name	1	20170505
af7ea8c4-c902-5a51-fdbc-62597b8c28f9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7419-04	valganciclovir hydrochloride	100 mL in 1 BOTTLE	FOR SOLUTION	100		2
0904-7419-04	valganciclovir hydrochloride	1 in 1 CARTON	FOR SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7419-04	ML - Milliliter	0904-7419	d4e1d2a2-af40-4fc4-82ee-f9ee04da2afb	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7419	VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION [MAJOR PHARMACEUTICALS]	1	Current NDC, 2 package rows	20240107_f656a741-7f9c-4173-8893-c259b0d96f5b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALGANCICLOVIR	VALGANCICLOVIR	airis PHARMA PVT LTD	ddfb4e0e-64f5-4654-8670-91b8b6abe794	2022-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210169 application number: ANDA210169
valganciclovir hydrochloride	VALGANCICLOVIR HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	614ff447-7e5f-4ea6-ba85-ec1f6497b360	2022-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210169 application number: ANDA210169

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4P3T9QF9NZ	VALGANCICLOVIR HYDROCHLORIDE	175865-59-5	VALGANCICLOVIR HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7419-04	00904741904	1 BOTTLE in 1 CARTON (0904-7419-04) / 100 mL in 1 BOTTLE	1 bottle	2024-01-05	2026-05-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
valganciclovir hydrochloride	MAJOR PHARMACEUTICALS \| MSN Pharmaceuticals Inc.	2026-02-26	Human Prescription Drug Label	2