VALACYCLOVIR

Product NDC: 51660-904
11-digit product format: 516600904
Labeler code: 51660
Product ID: 51660-904_623aa8f4-d84d-4dae-9fcb-51e2b288d52a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VALACYCLOVIR HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Ohm Laboratories Inc.
Application: ANDA076588
Marketing category: ANDA
Marketing start: 2009-11-25
Marketing end: 0000-00-00
Substance: VALACYCLOVIR HYDROCHLORIDE
Active strength: 500 mg/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: E
Listing certified through: 2018-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51660-904		D	Discontinued by firm	2026-08-17
excluded package	package	51660-904	51660-904-03	D	Discontinued by firm	2026-08-17
excluded package	package	51660-904	51660-904-05	D	Discontinued by firm	2026-08-17
excluded package	package	51660-904	51660-904-30	D	Discontinued by firm	2026-08-17
excluded package	package	51660-904	51660-904-77	D	Discontinued by firm	2026-08-17
excluded package	package	51660-904	51660-904-90	D	Discontinued by firm	2026-08-17

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 3 · 132 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	51660-904-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51660-904-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51660-904-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51660-904-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51660-904-77	`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	51660-904-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51660-904-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51660-904-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51660-904-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51660-904-77	`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	51660-904-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51660-904-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51660-904-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51660-904-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51660-904-77	`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	51660-904-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51660-904-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51660-904-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51660-904-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51660-904-77	`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	51660-904-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51660-904-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51660-904-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51660-904-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51660-904-77	`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	51660-904-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51660-904-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51660-904-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51660-904-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51660-904-77	`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	51660-904-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51660-904-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51660-904-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51660-904-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51660-904-77	`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	51660-904-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51660-904-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51660-904-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51660-904-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51660-904-77	`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	51660-904-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51660-904-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51660-904-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51660-904-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51660-904-77	`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	51660-904-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51660-904-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51660-904-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51660-904-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51660-904-77	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076588-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2007-01-31
A076588-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2007-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076588-001	AB
A076588-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076588-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076588-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076588-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51660-904-03	These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995
51660-904-05	These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995
51660-904-30	These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995
51660-904-77	These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995
51660-904-90	These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51660-904	VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]	1	Legacy NDC	20140228_51f93a1c-90d0-4cbc-90f7-6f1415efd673.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
Valacyclovir	VALACYCLOVIR	Golden State Medical Supply, Inc.	e3b4757b-d97b-6714-e053-2995a90a64eb	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588
Valacyclovir	VALACYCLOVIR	SUN PHARMACEUTICAL INDUSTRIES, INC.	26634bf1-c6d8-4d48-9a4e-845c47df07f8	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALACYCLOVIR	Ohm Laboratories Inc. \| Ranbaxy Pharmaceuticals Inc. \| RANBAXY LABORATORIES LIMITED	2013-09-24	HUMAN PRESCRIPTION DRUG LABEL	1