VALTREX

Product NDC: 67296-0200
Requested package NDC: 67296-0200-1
11-digit product format: 672960200
Labeler code: 67296
Product ID: 67296-0200_d5fbf428-e6ed-0abc-e053-2a95a90a694d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug
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: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0200	67296-0200-1	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0200-1	2024-01-30	C162847	48780-1	1030e364-fe70-111a-e063-dadaa90a10e2	Valtrex 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0200-1	VALTREX	21 in 1 BOTTLE	TABLET, FILM COATED	21		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0200	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG]	4	Legacy NDC, 1 package rows	20220120_b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313564	valACYclovir 1 GM Oral Tablet	PSN	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
212448	VALTREX 1 GM Oral Tablet	PSN	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
212448	valacyclovir 1000 MG Oral Tablet [Valtrex]	SBD	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
313564	valacyclovir 1 GM Oral Tablet	SY	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
212448	Valtrex (as valacyclovir hydrochloride) 1000 MG Oral Tablet	SY	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
212448	Valtrex 1 GM Oral Tablet	SY	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4
212448	Valtrex 1000 MG Oral Tablet	SY	b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0200-1	67296020001	21 TABLET, FILM COATED in 1 BOTTLE (67296-0200-1)	2002-08-12	0000-00-00	No	No	Current