Valacyclovir Hydrochloride

Product NDC: 53002-0061
Requested package NDC: 53002-0061-3
11-digit product format: 530020061
Labeler code: 53002
Product ID: 53002-0061_2cb39722-4943-4b29-b82a-15f75c070100
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090682
Marketing category: ANDA
Marketing start: 2010-05-24
Marketing end: 0000-00-00
Substance: VALACYCLOVIR HYDROCHLORIDE
Active strength: 1 g/1
Pharmacologic classes: DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-0061	53002-0061-3	I	Inactivated by FDA		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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090682-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2010-05-24
A090682-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2010-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090682-001	AB
A090682-002	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 3 · 82 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	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090682-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090682-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090682-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090682-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090682-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090682-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090682-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090682-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090682-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090682-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090682-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090682-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090682-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090682-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090682-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33190c02-82e1-0a4d-d716-9ccd23588463	Product name	5	20250225
c367d1da-5a72-8966-6d11-1eb9a73ae758	Product name	3	20231115
5518bf13-db2f-2e9c-3679-e70ecf03752c	Product name	9	20210614
27897900-0e40-497b-97e1-88057e68fe6c	Product name	4	20200710
ca834e59-e669-229c-9288-0ccb76dc373e	Product name	9	20200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28	Product name	1	20190702
fb15b394-3715-4c87-a447-421489aa8739	Product name	3	20170727
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-0061-0	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-1	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-2	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-3	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-4	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-5	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-6	2025-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-0	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-1	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-2	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-3	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-4	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-5	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-6	2023-06-07	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-0	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-1	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-2	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-3	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-4	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-5	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-6	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-0	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-1	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-2	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-3	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-4	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-5	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-6	2020-12-15	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-0	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-1	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-2	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-3	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-4	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-5	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-6	2020-01-31	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-0061-0	Valacyclovir Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
53002-0061-1	Valacyclovir Hydrochloride	2 in 1 BOTTLE	TABLET, FILM COATED	2	7
53002-0061-2	Valacyclovir Hydrochloride	4 in 1 BOTTLE	TABLET, FILM COATED	4	7
53002-0061-3	Valacyclovir Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	7
53002-0061-4	Valacyclovir Hydrochloride	14 in 1 BOTTLE	TABLET, FILM COATED	14	7
53002-0061-5	Valacyclovir Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	7
53002-0061-6	Valacyclovir Hydrochloride	21 in 1 BOTTLE	TABLET, FILM COATED	21	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-0061	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	7	Legacy NDC, 7 package rows	20230609_1ef0f51a-f730-435c-bc0d-2175fee91a9e.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	a56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	275c0198-10a5-139e-e063-6394a90a72be	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	93dccd99-d28b-4c47-872c-c3c0001b8a7f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a888812-2867-4dd3-b56e-2d98da837d1f	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NorthStar Rx LLC	4acf51de-26f7-42b2-8acc-61b800627ef3	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	7681a6f4-a6e7-4277-adbd-38837d5ead6b	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	de96c14b-cd74-46dd-bcce-d1fa640a6037	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	8c0be4f6-2d11-41d4-8f57-4f8db9da60b2	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Major Pharmaceuticals	fd982aee-d503-47b3-8d3d-42e9a8690457	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	87ec59e3-c06a-4ca7-bc65-5b251263ab3b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	df34e11d-5f2c-4755-b84b-b95d1d7b73f0	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Rising Pharma Holdings, Inc.	8d1645c0-fd03-4992-9372-98026a26b3af	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae8d15a4-1ed5-4e3c-9672-0f4735322a1c	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e300970d-1145-4460-a8c8-f6e1654c2c3d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	458bb24a-4f97-4003-93cb-356906a432c9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f32d5f04-4198-82a5-e053-2995a90a1841	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f98aea50-e4d9-c0cc-e053-6294a90a811c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	fb875f07-e9a0-48eb-a8b0-16ea7bbae9ab	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Aurobindo Pharma Limited	f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE	124832-27-5	VALACYCLOVIR HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313564	valACYclovir 1 GM Oral Tablet	PSN	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313565	valACYclovir 500 MG Oral Tablet	PSN	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir 1000 MG Oral Tablet	SCD	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313565	valacyclovir 500 MG Oral Tablet	SCD	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir 1 GM Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-0061-3	53002006103	10 TABLET, FILM COATED in 1 BOTTLE (53002-0061-3)	2018-10-01	0000-00-00	No	No	Current