Valacyclovir

Product NDC: 60760-856
11-digit product format: 607600856
Labeler code: 60760
Product ID: 60760-856_5903c85c-6b69-ab83-e063-6294a90a3694
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA209553
Marketing category: ANDA
Marketing start: 2026-08-12
Substance: VALACYCLOVIR HYDROCHLORIDE
Active strength: 1000 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: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209553-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2020-03-18
A209553-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2020-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209553-001	AB
A209553-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209553-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209553-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209553-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209553-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209553-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209553-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209553-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209553-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209553-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209553-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209553-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209553-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209553-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209553-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209553-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209553-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209553-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209553-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	1000 mg/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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313564	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
5903c8eb-8538-adad-e063-6294a90a5fed	Available on FDA.report

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	Sportpharm LLC	14e479b1-8afd-4912-8f93-59b60a0868bc	2026-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	f30b9f67-0c2e-45c2-a480-07eddee0d2db	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	St. Mary's Medical Park Pharmacy	5903c8eb-8538-adad-e063-6294a90a5fed	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553 ndc (product): 60760-856
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	5e39bf80-ada6-4194-bf3d-2c044c3389da	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	6ff2068f-1002-4d84-bd65-081d5b4082b1	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Westminster Pharmaceuticals, LLC	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	890f45c7-191b-4d60-8c52-ed92c2319eb3	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Redpharm Drug	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Yiling Pharmaceutical, Inc.	f3ee4017-a4fc-475d-a49b-b39168ec5966	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Chartwell RX, LLC	e59f15d0-c32a-4848-bdd5-fc2542e561c0	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Direct _Rx	26a43531-c62a-9e7f-e063-6394a90a8d3f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	3146e367-8438-4141-9368-95ce6f59c724	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Direct_Rx	387c9c12-4735-1f9d-e063-6394a90a030c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	65d13d0e-cf7f-4422-81f1-3dfce4722718	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	5af8f909-ad53-480e-9176-43f95dcc218a	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	b713ebfb-096e-445e-ab15-129aca20fadf	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	6719e877-cff4-4be8-a352-8df0afa4f74c	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals,Inc.	1ac7a13e-3f30-e140-e063-6394a90aa09d	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	a3a6a874-f568-429d-96b4-8ef89393564f	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	659a7c36-378a-4392-bb13-948337caf17f	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE	124832-27-5	VALACYCLOVIR HYDROCHLORIDE
MZ1IW7Q79D	VALACYCLOVIR	124832-26-4	Valacyclovir

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-856-42	60760085642	42 TABLET in 1 BOTTLE, PLASTIC (60760-856-42)	42 tablet	2026-08-12	No	No	Current