VALGANCICLOVIR HYDROCHLORIDE

Product NDC: 70069-810
11-digit product format: 700690810
Labeler code: 70069
Product ID: 70069-810_48f8965d-d9ca-7c96-e063-6394a90af350
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALGANCICLOVIR
Dosage form: FOR SOLUTION
Route: ORAL
Labeler: Somerset Therapeutics, LLC
Application: ANDA213306
Marketing category: ANDA
Marketing start: 2022-01-15
Substance: VALGANCICLOVIR
Active strength: 50 mg/mL
Pharmacologic classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], 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
A213306-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB		2020-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213306-001	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
2026-02-19 14:30 UTC	2026-02	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL		2020-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL		2020-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL		2020-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL		2020-01-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213306-001	VALGANCICLOVIR HYDROCHLORIDE	50MG/ML	FOR SOLUTION / ORAL	AB	2020-01-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213306-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213306-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213306-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213306-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213306-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213306-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213306-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213306-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213306-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213306-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213306-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213306-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213306-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213306-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213306-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213306-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213306-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213306-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213306-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213306-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213306-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213306-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213306-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213306-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213306-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213306-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213306-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213306-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213306-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213306-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213306-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213306-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213306-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: VALGANCICLOVIR HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALGANCICLOVIR	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GCU97FKN3R	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
b856bfaf-ec6b-4171-81c4-b9b07f780084	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70069-810-01	VALGANCICLOVIR HYDROCHLORIDE	100 mL in 1 BOTTLE	FOR SOLUTION	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-810-01	ML - Milliliter	70069-810	c1d446c8-1eb6-4d04-b2f6-a7ded0658f3a	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-810	VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR) FOR SOLUTION [SOMERSET THERAPEUTICS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240131_b856bfaf-ec6b-4171-81c4-b9b07f780084.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	VALGANCICLOVIR	Somerset Therapeutics, LLC	b856bfaf-ec6b-4171-81c4-b9b07f780084	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213306 application number: ANDA213306 ndc (product): 70069-810
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR	Granules Pharmaceuticals Inc.	39452b74-161d-4525-a0f7-fe486f001513	2024-02-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213306 application number: ANDA213306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GCU97FKN3R	VALGANCICLOVIR	175865-60-8	VALGANCICLOVIR

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	b856bfaf-ec6b-4171-81c4-b9b07f780084	4
863559	valganciclovir 50 MG/ML Oral Solution	SCD	b856bfaf-ec6b-4171-81c4-b9b07f780084	4
863559	valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral Solution	SY	b856bfaf-ec6b-4171-81c4-b9b07f780084	4
863559	valganciclovir 50 MG per 1 ML Oral Solution	SY	b856bfaf-ec6b-4171-81c4-b9b07f780084	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70069-810-01	70069081001	100 mL in 1 BOTTLE (70069-810-01)	100 ml	2022-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALGANCICLOVIR HYDROCHLORIDE	Somerset Therapeutics, LLC	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	4