Application 020487

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALTREX	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	Yes	No
002	VALTREX	VALACYCLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 1GM BASE	Yes	Yes

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…`

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 ndc (product): 70518-2039
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 ndc (product): 0173-0565 ndc (product): 0173-0933

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0565	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0933	VALTREX	valacyclovir hydrochloride	GlaxoSmithKline LLC	NDA	Current
50090-0753	VALTREX	valacyclovir hydrochloride	A-S Medication Solutions	NDA	Current
55289-926	VALTREX	valacyclovir hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3982	VALTREX	valacyclovir hydrochloride	Bryant Ranch Prepack	NDA	Current
67296-0200	VALTREX	valacyclovir hydrochloride	RedPharm Drug	NDA	Current
67296-0200	VALTREX	valacyclovir hydrochloride	RedPharm Drug	NDA	Current
70518-2039	VALTREX	valacyclovir hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2039	VALTREX	valacyclovir hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84159	SUPPL	2025-11-13
84154	SUPPL	2025-11-13
67822	SUPPL	2021-06-15
67817	SUPPL	2021-06-15
61240	SUPPL	2019-12-11
61228	SUPPL	2019-12-11
25035	SUPPL	2010-04-22
34702	SUPPL	2010-04-20
25034	SUPPL	2008-09-09
34701	SUPPL	2008-09-03
2594	SUPPL	2008-01-09
12630	SUPPL	2007-12-14
25033	SUPPL	2005-11-30
12629	SUPPL	2005-11-30
41392	SUPPL	2005-06-27
41391	SUPPL	2005-06-27
41390	SUPPL	2005-06-27
20678	SUPPL	2005-06-27
34700	SUPPL	2004-12-08
25032	SUPPL	2004-12-08
66491	ORIG	1900-01-01
66490	ORIG	1900-01-01
53433	ORIG	1900-01-01
53432	ORIG	1900-01-01
53431	ORIG	1900-01-01