Valganciclovir hydrochloride for Oral

Product NDC: 0591-2579
11-digit product format: 005912579
Labeler code: 0591
Product ID: 0591-2579_51bfc674-3cf7-4d5d-9ca8-b7863b2e49b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir hydrochloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA205220
Marketing category: ANDA
Marketing start: 2016-08-26
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205220-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205220-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205220-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205220-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205220-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205220-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205220-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205220-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205220-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205220-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205220-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205220-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205220-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205220-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205220-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205220-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205220-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205220-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205220-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205220-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205220-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205220-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205220-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205220-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205220-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205220-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205220-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205220-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205220-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205220-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205220-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205220-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205220-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205220-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205220-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205220-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205220-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205220-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205220-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205220-001	AB	1	`cb3db0bc1861…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92281301-5fb5-4eea-8766-4863e241c234	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86	Product name	9	20221206
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
9f9c8b60-edb9-4f29-9472-12fa266e8ead	Product name	5	20190912
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
db601a58-ade5-4a08-a9d0-73d4222e8e5a	Product name	1	20170505
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
af7ea8c4-c902-5a51-fdbc-62597b8c28f9	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2579-20	Valganciclovir hydrochloride for Oral	100 mL in 1 BOTTLE, GLASS	POWDER, FOR SOLUTION	100		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2579-20	ML - Milliliter	0591-2579	3e757b6f-b8d3-49df-b854-ce2b85b8a387	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2579	VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.]	23	Current NDC, Legacy NDC, 1 package rows	20230331_92281301-5fb5-4eea-8766-4863e241c234.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 hydrochloride for Oral	VALGANCICLOVIR HYDROCHLORIDE	AvKARE	07eb5abf-2322-4fb9-e063-6394a90a2311	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205220 application number: ANDA205220
Valganciclovir hydrochloride for Oral	VALGANCICLOVIR HYDROCHLORIDE	Actavis Pharma, Inc.	92281301-5fb5-4eea-8766-4863e241c234	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205220 application number: ANDA205220 ndc (product): 0591-2579

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863559	valGANciclovir 50 MG in 1 mL Oral Solution	PSN	92281301-5fb5-4eea-8766-4863e241c234	24
863559	valganciclovir 50 MG/ML Oral Solution	SCD	92281301-5fb5-4eea-8766-4863e241c234	24
863559	valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral Solution	SY	92281301-5fb5-4eea-8766-4863e241c234	24
863559	valganciclovir 50 MG per 1 ML Oral Solution	SY	92281301-5fb5-4eea-8766-4863e241c234	24
863559	valGANciclovir 50 MG in 1 mL Oral Solution	PSN	07eb5abf-2322-4fb9-e063-6394a90a2311	2
863559	valganciclovir 50 MG/ML Oral Solution	SCD	07eb5abf-2322-4fb9-e063-6394a90a2311	2
863559	valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral Solution	SY	07eb5abf-2322-4fb9-e063-6394a90a2311	2
863559	valganciclovir 50 MG per 1 ML Oral Solution	SY	07eb5abf-2322-4fb9-e063-6394a90a2311	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2579-20	00591257920	100 mL in 1 BOTTLE, GLASS (0591-2579-20)	100 ml	2016-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valganciclovir hydrochloride for Oral	AvKARE	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Valganciclovir hydrochloride for Oral	Actavis Pharma, Inc.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	24