Application 090682

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

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

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…`

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Cardinal Health 107, LLC	72300f70-57fd-42a8-a2dc-4cf95a1ce805	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	de96c14b-cd74-46dd-bcce-d1fa640a6037	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Redpharm Drug	57e5cc11-f3cb-6266-e063-6394a90afc47	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	REMEDYREPACK INC.	740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	a56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	275c0198-10a5-139e-e063-6394a90a72be	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Bryant Ranch Prepack	93dccd99-d28b-4c47-872c-c3c0001b8a7f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682 ndc (product): 71335-0708
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a888812-2867-4dd3-b56e-2d98da837d1f	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	NorthStar Rx LLC	4acf51de-26f7-42b2-8acc-61b800627ef3	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	7681a6f4-a6e7-4277-adbd-38837d5ead6b	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	8c0be4f6-2d11-41d4-8f57-4f8db9da60b2	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Major Pharmaceuticals	fd982aee-d503-47b3-8d3d-42e9a8690457	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	87ec59e3-c06a-4ca7-bc65-5b251263ab3b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	A-S Medication Solutions	df34e11d-5f2c-4755-b84b-b95d1d7b73f0	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Rising Pharma Holdings, Inc.	8d1645c0-fd03-4992-9372-98026a26b3af	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae8d15a4-1ed5-4e3c-9672-0f4735322a1c	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682 ndc (product): 72789-263
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e300970d-1145-4460-a8c8-f6e1654c2c3d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682 ndc (product): 72789-264
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Sportpharm LLC	458bb24a-4f97-4003-93cb-356906a432c9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f32d5f04-4198-82a5-e053-2995a90a1841	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Northwind Health Company, LLC	f98aea50-e4d9-c0cc-e053-6294a90a811c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090682 application number: ANDA090682

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 167 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0708	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0708	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1862	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-263	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-263	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-264	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-053	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride	Asclemed USA, Inc.	ANDA	Current