VALGANCICLOVIR HYDROCHLORIDE

Product NDC: 70010-051
11-digit product format: 700100051
Labeler code: 70010
Product ID: 70010-051_1292e397-2837-b544-e063-6394a90a229b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALGANCICLOVIR
Dosage form: FOR SOLUTION
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA213306
Marketing category: ANDA
Marketing start: 2021-07-01
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: 2026-12-31
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: 2026-12-31

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
39452b74-161d-4525-a0f7-fe486f001513	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
70010-051-40	VALGANCICLOVIR HYDROCHLORIDE	100 mL in 1 BOTTLE	FOR SOLUTION	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-051-40	ML - Milliliter	70010-051	5842b0e2-8cef-489f-ba6a-e8a846fee33e	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-051	VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR) FOR SOLUTION [GRANULES PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 1 package rows	20240302_39452b74-161d-4525-a0f7-fe486f001513.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
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 ndc (product): 70010-051

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	39452b74-161d-4525-a0f7-fe486f001513	10
863559	valganciclovir 50 MG/ML Oral Solution	SCD	39452b74-161d-4525-a0f7-fe486f001513	10
863559	valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral Solution	SY	39452b74-161d-4525-a0f7-fe486f001513	10
863559	valganciclovir 50 MG per 1 ML Oral Solution	SY	39452b74-161d-4525-a0f7-fe486f001513	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-051-40	70010005140	100 mL in 1 BOTTLE (70010-051-40)	100 ml	2021-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALGANCICLOVIR HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	10