Valacyclovir Hydrochloride

Product NDC: 57237-043
11-digit product format: 572370043
Labeler code: 57237
Product ID: 57237-043_a9ee543a-9c63-46df-99f9-cd085ce08bee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090682-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090682-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A090682-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090682-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090682-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090682-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8d1645c0-fd03-4992-9372-98026a26b3af	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	SPL version
57237-043-05	Valacyclovir Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	10
57237-043-30	Valacyclovir Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
57237-043-90	Valacyclovir Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-043-30	EA - Each	57237-043	84b9c2fc-8276-4db1-b4a8-0eb36d5e998a	1	2014-04-03
57237-043-90	EA - Each	57237-043	5f662e2c-527e-4c59-b594-f1f170ed4809	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-043	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20240113_8d1645c0-fd03-4992-9372-98026a26b3af.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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	REMEDYREPACK INC.	de96c14b-cd74-46dd-bcce-d1fa640a6037	2026-04-08	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 ndc (product): 57237-043
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
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
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
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

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	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	103
313564	valacyclovir 1000 MG Oral Tablet	SCD	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	103
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	103
313564	valacyclovir 1 GM Oral Tablet	SY	4619bcc6-0070-4f3b-9cf9-900f3e5f7b19	103
313564	valACYclovir 1 GM Oral Tablet	PSN	8d1645c0-fd03-4992-9372-98026a26b3af	10
313565	valACYclovir 500 MG Oral Tablet	PSN	8d1645c0-fd03-4992-9372-98026a26b3af	10
313564	valacyclovir 1000 MG Oral Tablet	SCD	8d1645c0-fd03-4992-9372-98026a26b3af	10
313565	valacyclovir 500 MG Oral Tablet	SCD	8d1645c0-fd03-4992-9372-98026a26b3af	10
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	8d1645c0-fd03-4992-9372-98026a26b3af	10
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	8d1645c0-fd03-4992-9372-98026a26b3af	10
313564	valacyclovir 1 GM Oral Tablet	SY	8d1645c0-fd03-4992-9372-98026a26b3af	10
313564	valACYclovir 1 GM Oral Tablet	PSN	de96c14b-cd74-46dd-bcce-d1fa640a6037	8
313564	valacyclovir 1000 MG Oral Tablet	SCD	de96c14b-cd74-46dd-bcce-d1fa640a6037	8
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	de96c14b-cd74-46dd-bcce-d1fa640a6037	8
313564	valacyclovir 1 GM Oral Tablet	SY	de96c14b-cd74-46dd-bcce-d1fa640a6037	8
313564	valACYclovir 1 GM Oral Tablet	PSN	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valACYclovir 1 GM Oral Tablet	PSN	8022eb52-da04-eb0a-e053-2a91aa0a6f87	7
313565	valACYclovir 500 MG Oral Tablet	PSN	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir 1000 MG Oral Tablet	SCD	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir 1000 MG Oral Tablet	SCD	8022eb52-da04-eb0a-e053-2a91aa0a6f87	7
313565	valacyclovir 500 MG Oral Tablet	SCD	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	8022eb52-da04-eb0a-e053-2a91aa0a6f87	7
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valacyclovir 1 GM Oral Tablet	SY	8022eb52-da04-eb0a-e053-2a91aa0a6f87	7
313564	valacyclovir 1 GM Oral Tablet	SY	1ef0f51a-f730-435c-bc0d-2175fee91a9e	7
313564	valACYclovir 1 GM Oral Tablet	PSN	268af320-810a-48de-9a08-9850be2878e3	6
313564	valacyclovir 1000 MG Oral Tablet	SCD	268af320-810a-48de-9a08-9850be2878e3	6
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	268af320-810a-48de-9a08-9850be2878e3	6
313564	valacyclovir 1 GM Oral Tablet	SY	268af320-810a-48de-9a08-9850be2878e3	6
313564	valACYclovir 1 GM Oral Tablet	PSN	802308ed-8c26-fed5-e053-2a91aa0a42b0	5
313564	valacyclovir 1000 MG Oral Tablet	SCD	802308ed-8c26-fed5-e053-2a91aa0a42b0	5
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	802308ed-8c26-fed5-e053-2a91aa0a42b0	5
313564	valacyclovir 1 GM Oral Tablet	SY	802308ed-8c26-fed5-e053-2a91aa0a42b0	5
313564	valACYclovir 1 GM Oral Tablet	PSN	552b806d-97d2-364d-e054-00144ff8d46c	4
313564	valACYclovir 1 GM Oral Tablet	PSN	f98aea50-e4d9-c0cc-e053-6294a90a811c	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	f98aea50-e4d9-c0cc-e053-6294a90a811c	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	552b806d-97d2-364d-e054-00144ff8d46c	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	f98aea50-e4d9-c0cc-e053-6294a90a811c	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	552b806d-97d2-364d-e054-00144ff8d46c	4
313564	valacyclovir 1 GM Oral Tablet	SY	f98aea50-e4d9-c0cc-e053-6294a90a811c	4
313564	valacyclovir 1 GM Oral Tablet	SY	552b806d-97d2-364d-e054-00144ff8d46c	4
313564	valACYclovir 1 GM Oral Tablet	PSN	95ad932a-0a49-6100-e053-2995a90a7848	3
313565	valACYclovir 500 MG Oral Tablet	PSN	95ad932a-0a49-6100-e053-2995a90a7848	3
313564	valacyclovir 1000 MG Oral Tablet	SCD	95ad932a-0a49-6100-e053-2995a90a7848	3
313565	valacyclovir 500 MG Oral Tablet	SCD	95ad932a-0a49-6100-e053-2995a90a7848	3
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	95ad932a-0a49-6100-e053-2995a90a7848	3
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	95ad932a-0a49-6100-e053-2995a90a7848	3
313564	valacyclovir 1 GM Oral Tablet	SY	95ad932a-0a49-6100-e053-2995a90a7848	3
313564	valACYclovir 1 GM Oral Tablet	PSN	8422aeeb-0c3b-478d-82fb-ca051809db01	2
313564	valacyclovir 1000 MG Oral Tablet	SCD	8422aeeb-0c3b-478d-82fb-ca051809db01	2
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	8422aeeb-0c3b-478d-82fb-ca051809db01	2
313564	valacyclovir 1 GM Oral Tablet	SY	8422aeeb-0c3b-478d-82fb-ca051809db01	2
313564	valACYclovir 1 GM Oral Tablet	PSN	275c0198-10a5-139e-e063-6394a90a72be	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	275c0198-10a5-139e-e063-6394a90a72be	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	275c0198-10a5-139e-e063-6394a90a72be	1
313564	valacyclovir 1 GM Oral Tablet	SY	275c0198-10a5-139e-e063-6394a90a72be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-043-05	57237004305	500 TABLET, FILM COATED in 1 BOTTLE (57237-043-05)	2010-05-24	0000-00-00	No	No	Current
57237-043-30	57237004330	30 TABLET, FILM COATED in 1 BOTTLE (57237-043-30)	2010-05-24	0000-00-00	No	No	Current
57237-043-90	57237004390	90 TABLET, FILM COATED in 1 BOTTLE (57237-043-90)	2010-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir Hydrochloride	St. Mary's Medical Park Pharmacy	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
Valacyclovir Hydrochloride	REMEDYREPACK INC.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	8
Valacyclovir Hydrochloride	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-03-10	Human Prescription Drug Label	10
Valacyclovir Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Valacyclovir Hydrochloride	NuCare Pharmacuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	4
Valacyclovir Hydrochloride	NuCare Pharmaceuticals,Inc.	2025-04-24	HUMAN PRESCRIPTION DRUG LABEL	5
Valacyclovir Hydrochloride	Preferred Pharmaceuticals Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Valacyclovir Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-12-02	HUMAN PRESCRIPTION DRUG LABEL	7
Valacyclovir Hydrochloride	Bryant Ranch Prepack	2024-08-28	HUMAN PRESCRIPTION DRUG LABEL	103
Valacyclovir Hydrochloride	A-S Medication Solutions	2023-12-10	Human Prescription Drug Label	19
Valacyclovir Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	7
Valacyclovir Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Valacyclovir Hydrochloride	Proficient Rx LP	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	6
Valacyclovir Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-10-01	HUMAN PRESCRIPTION DRUG LABEL	3
Valacyclovir Hydrochloride	NuCare Pharmaceuticals, Inc.	2021-03-19	HUMAN PRESCRIPTION DRUG LABEL	4
Valacyclovir Hydrochloride	NuCare Pharmaceuticals, Inc.	2017-07-11	HUMAN PRESCRIPTION DRUG LABEL	1