Valganciclovir

Product NDC: 0603-6330
11-digit product format: 006036330
Labeler code: 0603
Product ID: 0603-6330_2ef2c711-9b0e-42fa-aa3e-58797bc86a33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA200790
Marketing category: ANDA
Marketing start: 2014-11-04
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 [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0603-6330		D	Discontinued by firm		2026-08-11
excluded package	package	0603-6330	0603-6330-20	D	Discontinued by firm		2026-08-11

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 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-6330-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-6330-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-6330-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-6330-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-6330-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-6330-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-6330-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-6330-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-6330-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-6330-20	`ad56d346431e…`	`cc804d4bbf1e…`

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
A200790-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB		2014-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200790-001	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	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`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	A200790-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200790-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200790-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200790-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200790-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200790-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200790-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200790-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200790-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200790-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200790-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200790-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200790-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200790-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200790-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200790-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200790-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200790-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200790-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200790-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200790-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200790-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200790-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200790-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200790-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200790-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200790-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200790-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200790-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200790-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200790-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200790-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200790-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200790-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200790-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200790-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200790-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200790-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200790-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200790-001	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
0603-6330-20	EA - Each	0603-6330	8eba9d72-6638-496b-a126-d8d9640827fe	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALGANCICLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	4P3T9QF9NZ	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
GANCICLOVIR	ACTIVE MOIETY	P9G3CKZ4P5	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	10

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 HYDROCHLORIDE	AvKARE	0d0bbc91-27f6-29bc-e063-6394a90a0027	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	89a934f0-85a3-44c1-82e5-d09d1738e08d	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	390691b2-3db0-4b9f-934f-120674726f14	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-6330-20	00603633020	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20)	2014-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valganciclovir	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Valganciclovir	AvKARE	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	4
Valganciclovir	Par Pharmaceutical	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	15