VALTREX

Product NDC: 63629-3982
11-digit product format: 636293982
Labeler code: 63629
Product ID: 63629-3982_291423bd-d8d3-4438-935c-f131dc57523a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA020487
Marketing category: NDA
Marketing start: 2002-08-12
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: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3982		D	Discontinued by firm	2026-08-17
excluded package	package	63629-3982	63629-3982-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3982	63629-3982-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3982	63629-3982-3	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 1 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3982-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3982-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3982-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3982-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3982-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3982-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3982-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3982-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3982-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3982-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3982-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3982-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3982-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3982-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3982-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3982-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3982-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3982-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3982-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3982-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3982-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3982-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3982-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3982-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3982-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3982-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3982-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3982-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3982-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3982-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3982-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3982-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3982-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3982-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3982-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3982-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-3982-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-3982-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-3982-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-3982-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-3982-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-3982-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-3982-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-3982-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-3982-3	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
N020487-001	VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23
N020487-002	VALTREX	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	RLD	1995-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020487-001	AB
N020487-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD	1995-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020487-001	VALTREX	EQ 500MG BASE	TABLET / ORAL	AB	RLD	1995-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020487-002	VALTREX	EQ 1GM BASE	TABLET / ORAL	AB	RLD, RS	1995-06-23	`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	N020487-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020487-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020487-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020487-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020487-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020487-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020487-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020487-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020487-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020487-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020487-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020487-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020487-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020487-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020487-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020487-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020487-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020487-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020487-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020487-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020487-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020487-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020487-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020487-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020487-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020487-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020487-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020487-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020487-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020487-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020487-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020487-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020487-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020487-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020487-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020487-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020487-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3982-1	2021-09-10	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995
63629-3982-2	2021-09-10	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995
63629-3982-3	2021-09-10	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995
63629-3982-1	2019-11-27	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995
63629-3982-2	2019-11-27	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995
63629-3982-3	2019-11-27	These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir hydrochloride) Caplets Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3982-1	EA - Each	63629-3982	438bd427-99d9-403d-9b98-8a64b74ffe63	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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
VALTREX	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020487 application number: NDA020487
VALTREX	VALACYCLOVIR HYDROCHLORIDE	GlaxoSmithKline LLC	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020487 application number: NDA020487

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
VALTREX - Bryant Ranch Prepack	Bryant Ranch Prepack	2013-01-21	HUMAN PRESCRIPTION DRUG LABEL	1000