VALTREX

Product NDC: 0173-0565
11-digit product format: 001730565
Labeler code: 0173
Product ID: 0173-0565_753fde77-5750-4c98-a167-daa531f3d872
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA020487
Marketing category: NDA
Marketing start: 2002-08-12
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: 2026-12-31
Current FDA listing: 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: VALTREX
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G447S0T1VC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
108780	Internal RxNorm lookup
212448	Internal RxNorm lookup
313564	Internal RxNorm lookup
313565	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f8e0d8f8-cb73-4206-a484-88f5c4fbd719	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0173-0565-04	VALTREX	30 in 1 BOTTLE	TABLET, FILM COATED	30		31
0173-0565-10	VALTREX	90 in 1 BOTTLE	TABLET, FILM COATED	90		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0565-04	EA - Each	0173-0565	08339ee3-4b43-4f12-8598-327a91d9d258	1	2012-07-24
0173-0565-10	EA - Each	0173-0565	f1ea8976-0476-4a50-a205-82751d0fe5ac	1	2012-07-24

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
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	16
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0565	VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	29	Current NDC, Legacy NDC, 2 package rows	20240625_f8e0d8f8-cb73-4206-a484-88f5c4fbd719.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 ndc (product): 0173-0565

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	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313565	valACYclovir 500 MG Oral Tablet	PSN	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
212448	VALTREX 1 GM Oral Tablet	PSN	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
108780	VALTREX 500 MG Oral Tablet	PSN	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
212448	valacyclovir 1000 MG Oral Tablet [Valtrex]	SBD	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
108780	valacyclovir 500 MG Oral Tablet [Valtrex]	SBD	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313564	valacyclovir 1000 MG Oral Tablet	SCD	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313565	valacyclovir 500 MG Oral Tablet	SCD	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313564	valacyclovir 1 GM Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
212448	Valtrex (as valacyclovir hydrochloride) 1000 MG Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
108780	Valtrex (as valacyclovir hydrochloride) 500 MG Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
212448	Valtrex 1 GM Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
212448	Valtrex 1000 MG Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
108780	Valtrex 500 MG Oral Tablet	SY	f8e0d8f8-cb73-4206-a484-88f5c4fbd719	31
313564	valACYclovir 1 GM Oral Tablet	PSN	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
212448	VALTREX 1 GM Oral Tablet	PSN	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
212448	valacyclovir 1000 MG Oral Tablet [Valtrex]	SBD	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
313564	valacyclovir 1000 MG Oral Tablet	SCD	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
313564	valacyclovir 1 GM Oral Tablet	SY	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
212448	Valtrex (as valacyclovir hydrochloride) 1000 MG Oral Tablet	SY	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
212448	Valtrex 1 GM Oral Tablet	SY	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
212448	Valtrex 1000 MG Oral Tablet	SY	56a62c21-bead-4f3b-a24e-c3fd0b4a732f	14
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
313564	valACYclovir 1 GM Oral Tablet	PSN	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313565	valACYclovir 500 MG Oral Tablet	PSN	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
212448	VALTREX 1 GM Oral Tablet	PSN	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
108780	VALTREX 500 MG Oral Tablet	PSN	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
212448	valacyclovir 1000 MG Oral Tablet [Valtrex]	SBD	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
108780	valacyclovir 500 MG Oral Tablet [Valtrex]	SBD	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313564	valacyclovir 1000 MG Oral Tablet	SCD	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313565	valacyclovir 500 MG Oral Tablet	SCD	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313564	valacyclovir 1 GM Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
212448	Valtrex (as valacyclovir hydrochloride) 1000 MG Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
108780	Valtrex (as valacyclovir hydrochloride) 500 MG Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
212448	Valtrex 1 GM Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
212448	Valtrex 1000 MG Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
108780	Valtrex 500 MG Oral Tablet	SY	b4450539-78ec-4e8a-8cfc-56dcde7984a0	2
313564	valACYclovir 1 GM Oral Tablet	PSN	1f338cd7-3520-337b-e063-6294a90aa45d	1
212448	VALTREX 1 GM Oral Tablet	PSN	1f338cd7-3520-337b-e063-6294a90aa45d	1
212448	valacyclovir 1000 MG Oral Tablet [Valtrex]	SBD	1f338cd7-3520-337b-e063-6294a90aa45d	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	1f338cd7-3520-337b-e063-6294a90aa45d	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	1f338cd7-3520-337b-e063-6294a90aa45d	1
313564	valacyclovir 1 GM Oral Tablet	SY	1f338cd7-3520-337b-e063-6294a90aa45d	1
212448	Valtrex (as valacyclovir hydrochloride) 1000 MG Oral Tablet	SY	1f338cd7-3520-337b-e063-6294a90aa45d	1
212448	Valtrex 1 GM Oral Tablet	SY	1f338cd7-3520-337b-e063-6294a90aa45d	1
212448	Valtrex 1000 MG Oral Tablet	SY	1f338cd7-3520-337b-e063-6294a90aa45d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0565-04	00173056504	30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)	2002-08-12	0000-00-00	No	No	Current
0173-0565-10	00173056510	90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)	2002-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VALTREX	REMEDYREPACK INC.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	15
VALTREX	GlaxoSmithKline LLC	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	32
VALTREX	RedPharm Drug	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Valtrex 1gm	RedPharm Drug \| EPM Packaging	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	4
VALTREX - A-S Medication Solutions	A-S Medication Solutions	2017-10-28	HUMAN PRESCRIPTION DRUG LABEL	4
VALTREX - Bryant Ranch Prepack	Bryant Ranch Prepack	2013-01-21	HUMAN PRESCRIPTION DRUG LABEL	1000
VALTREX - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-09-04	HUMAN PRESCRIPTION DRUG LABEL	2