Valganciclovir

Product NDC: 63739-076
11-digit product format: 637390076
Labeler code: 63739
Product ID: 63739-076_e23418f8-cb6d-17d3-e053-2995a90a2256
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: McKesson Corporation DBA SKY Packaging
Application: ANDA205166
Marketing category: ANDA
Marketing start: 2022-03-07
Marketing end: 0000-00-00
Substance: VALGANCICLOVIR HYDROCHLORIDE
Active strength: 450 mg/1
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

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	63739-076		D	Discontinued by firm		2026-08-03
excluded package	package	63739-076	63739-076-33	D	Discontinued by firm		2026-08-03

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	63739-076		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63739-076	63739-076-33	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
A205166-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB		2016-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205166-001	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	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`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	A205166-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205166-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205166-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205166-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205166-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205166-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205166-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205166-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205166-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205166-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205166-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205166-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205166-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205166-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205166-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205166-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205166-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205166-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205166-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205166-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205166-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205166-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205166-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205166-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205166-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205166-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205166-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205166-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205166-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205166-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205166-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205166-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205166-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205166-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205166-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205166-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205166-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205166-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205166-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205166-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-076-33	EA - Each	63739-076	9dbf094f-ecd7-4155-a682-fe9e5eaade89	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-076	VALGANCICLOVIR TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]	9	Legacy NDC	20250115_d9b7ccf8-aec2-9f48-e053-2a95a90a5d04.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valganciclovir	VALGANCICLOVIR	Major Pharmaceuticals	6a6533fd-0579-4059-ba87-aa399829a8b0	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166
Valganciclovir	VALGANCICLOVIR	AvPAK	85177859-e0f5-6d83-17f3-29cae1db96c3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166
Valganciclovir	VALGANCICLOVIR	Camber Pharmaceuticals, Inc.	383e8810-b877-4a4f-abdf-c8c4c8e394f8	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4P3T9QF9NZ	VALGANCICLOVIR HYDROCHLORIDE	175865-59-5	VALGANCICLOVIR HYDROCHLORIDE
GCU97FKN3R	VALGANCICLOVIR	175865-60-8	Valganciclovir

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-076-33	63739007633	3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-076-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2022-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valganciclovir	McKesson Corporation DBA SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	9