Valacyclovir Hydrochloride

Product NDC: 67296-2293
11-digit product format: 672962293
Labeler code: 67296
Product ID: 67296-2293_57e5cc39-aebd-6df9-e063-6294a90a2c50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA090682
Marketing category: ANDA
Marketing start: 2010-05-24
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: 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
A090682-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2010-05-24
A090682-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2010-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090682-001	AB
A090682-002	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 · 86 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	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A090682-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090682-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090682-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090682-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090682-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090682-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090682-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090682-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090682-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090682-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090682-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090682-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090682-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090682-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090682-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090682-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090682-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090682-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090682-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090682-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090682-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090682-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090682-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090682-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090682-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090682-002	AB	1	`74a2ff9319b5…`

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 Hydrochloride
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 · 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
57e5cc11-f3cb-6266-e063-6394a90afc47	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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	fb875f07-e9a0-48eb-a8b0-16ea7bbae9ab	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Aurobindo Pharma Limited	f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	AvPAK	7f5fc62f-d043-db36-ce92-7adc4f7a79a5	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	82ddec27-79ac-40f4-afde-707f3940f893	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmacuticals,Inc.	552b806d-97d2-364d-e054-00144ff8d46c	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	802308ed-8c26-fed5-e053-2a91aa0a42b0	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	82bac944-417a-0af7-e053-2a91aa0a8674	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8422aeeb-0c3b-478d-82fb-ca051809db01	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	American Health Packaging	23fb4162-2310-486c-ba9f-f7c94b793e56	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8022eb52-da04-eb0a-e053-2a91aa0a6f87	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	e005139e-6f76-9b2f-e053-2a95a90ab0fb	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Asclemed USA, Inc.	1864bf8b-07a2-4b82-8592-bf8ad6f9f8f9	2024-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	883f643b-27f6-5a3e-e053-2995a90a8ff1	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	c6328ed5-a3d3-4948-94be-b226271d0311	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	268af320-810a-48de-9a08-9850be2878e3	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Asclemed USA, Inc.	b99b8309-dd80-422a-9b17-f20386dc4d8d	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE	124832-27-5	VALACYCLOVIR HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67296-2293-4	67296229304	21 TABLET, FILM COATED in 1 BOTTLE (67296-2293-4)	2010-05-24	No	No	Current