valacyclovir hydrochloride

Product NDC: 59746-324
11-digit product format: 597460324
Labeler code: 59746
Product ID: 59746-324_40211dd2-c21e-45a4-a8d4-04febf925f52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA201506
Marketing category: ANDA
Marketing start: 2012-04-05
Substance: VALACYCLOVIR HYDROCHLORIDE
Active strength: 500 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: 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
A201506-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2012-04-03
A201506-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2012-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201506-001	AB
A201506-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`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	A201506-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201506-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201506-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201506-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201506-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201506-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201506-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201506-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201506-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201506-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201506-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201506-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201506-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201506-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201506-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201506-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201506-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201506-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201506-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201506-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201506-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201506-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201506-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201506-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201506-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201506-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201506-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201506-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201506-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: valacyclovir hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	500 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 · 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
3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-324-01	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-10	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-30	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-37	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-47	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-90	2023-02-27	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-01	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-10	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-30	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-37	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-47	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
59746-324-90	2023-01-30	These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59746-324-01	valacyclovir hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	15
59746-324-10	valacyclovir hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	15
59746-324-30	valacyclovir hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
59746-324-37	valacyclovir hydrochloride	250 in 1 BOTTLE	TABLET, FILM COATED	250	15
59746-324-47	valacyclovir hydrochloride	300 in 1 BOTTLE	TABLET, FILM COATED	300	15
59746-324-90	valacyclovir hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-324-30	EA - Each	59746-324	9a28c131-7754-4e96-9c3e-32dd4a3cd5c2	1	2013-02-13
59746-324-37	EA - Each	59746-324	a5d8fe94-d467-4215-ac9f-0dc61479114f	1	2013-02-13
59746-324-90	EA - Each	59746-324	e87be3ed-41a3-4037-8c7d-b78af25cf59b	1	2024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Acyclovir	ACTIVE MOIETY	X4HES1O11F	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	3
Valacyclovir Hydrochloride	ACTIVE INGREDIENT	G447S0T1VC	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-324	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 6 package rows	20230904_3277c17e-f953-2b0a-fe0a-4f5d1aeace9d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	Direct Rx	cbd7bb49-7a9c-4383-a158-bfc307db0130	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	2023-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506 ndc (product): 59746-324
valacyclovir hydrochloride	VALACYCLOVIR HYDROCHLORIDE	Proficient Rx LP	efe37bd1-a236-43cc-828c-b57e8a704d67	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201506 application number: ANDA201506

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	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313565	valACYclovir 500 MG Oral Tablet	PSN	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313564	valacyclovir 1000 MG Oral Tablet	SCD	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313565	valacyclovir 500 MG Oral Tablet	SCD	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313564	valacyclovir 1 GM Oral Tablet	SY	3277c17e-f953-2b0a-fe0a-4f5d1aeace9d	15
313564	valACYclovir 1 GM Oral Tablet	PSN	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313565	valACYclovir 500 MG Oral Tablet	PSN	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313565	valacyclovir 500 MG Oral Tablet	SCD	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313564	valacyclovir 1 GM Oral Tablet	SY	ad17b820-e9b9-407b-94e1-614073feb6dd	4
313565	valACYclovir 500 MG Oral Tablet	PSN	cbd7bb49-7a9c-4383-a158-bfc307db0130	3
313565	valacyclovir 500 MG Oral Tablet	SCD	cbd7bb49-7a9c-4383-a158-bfc307db0130	3
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	cbd7bb49-7a9c-4383-a158-bfc307db0130	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-324-01	59746032401	100 TABLET, FILM COATED in 1 BOTTLE (59746-324-01)	2012-04-05	0000-00-00	No	No	Current
59746-324-10	59746032410	10 TABLET, FILM COATED in 1 BOTTLE (59746-324-10)	2012-04-05	0000-00-00	No	No	Current
59746-324-30	59746032430	30 TABLET, FILM COATED in 1 BOTTLE (59746-324-30)	2012-04-05	0000-00-00	No	No	Current
59746-324-37	59746032437	250 TABLET, FILM COATED in 1 BOTTLE (59746-324-37)	2012-04-05	0000-00-00	No	No	Current
59746-324-47	59746032447	300 TABLET, FILM COATED in 1 BOTTLE (59746-324-47)	2012-04-05	0000-00-00	No	No	Current
59746-324-90	59746032490	90 TABLET, FILM COATED in 1 BOTTLE (59746-324-90)	2012-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir	Direct Rx	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	3
valacyclovir hydrochloride	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited \| Graviti Pharmaceuticals Private Limited.	2023-08-30	Human Prescription Drug Label	15
valacyclovir hydrochloride	REMEDYREPACK INC.	2023-03-09	HUMAN PRESCRIPTION DRUG LABEL	7
valacyclovir hydrochloride	Unit Dose Services	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	4