Valacyclovir

Product NDC: 63304-904
Requested package NDC: 63304-904-05
11-digit product format: 633040904
Labeler code: 63304
Product ID: 63304-904_744b60c8-568b-4726-881c-68709c30f28a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SUN PHARMACEUTICAL INDUSTRIES, INC.
Application: ANDA076588
Marketing category: ANDA
Marketing start: 2020-12-19
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

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 3 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-904	63304-904-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63304-904	63304-904-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63304-904	63304-904-05	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A076588-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2007-01-31
A076588-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2007-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076588-001	AB
A076588-002	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	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076588-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2007-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076588-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2007-01-31	`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	A076588-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076588-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076588-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076588-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076588-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076588-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076588-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076588-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076588-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076588-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076588-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076588-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076588-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076588-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076588-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076588-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076588-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076588-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076588-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076588-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076588-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076588-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076588-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076588-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076588-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076588-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076588-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076588-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076588-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	Golden State Medical Supply, Inc.	e3b4757b-d97b-6714-e053-2995a90a64eb	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588
Valacyclovir	VALACYCLOVIR	SUN PHARMACEUTICAL INDUSTRIES, INC.	26634bf1-c6d8-4d48-9a4e-845c47df07f8	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076588 application number: ANDA076588 ndc (package): 63304-904-05 ndc (product): 63304-904 ndc11 (package): 63304090405

Additional Listing Data#

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

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
26634bf1-c6d8-4d48-9a4e-845c47df07f8	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63304-904-03	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-03	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-05	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-05	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-30	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-30	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-77	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-77	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-90	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-90	2020-12-19	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-03	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-03	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-05	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-05	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-30	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-30	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-77	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-77	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-90	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-90	2020-01-31	C162847	48780-1	9d75b9d0-769f-f424-e053-dadaa90a57ce	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
63304-904-03	Valacyclovir	10 in 1 BOTTLE	TABLET, FILM COATED	10	18
63304-904-05	Valacyclovir	500 in 1 BOTTLE	TABLET, FILM COATED	500	18
63304-904-11	Valacyclovir	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	18
63304-904-30	Valacyclovir	30 in 1 BOTTLE	TABLET, FILM COATED	30	18
63304-904-77	Valacyclovir	100 in 1 CARTON	TABLET, FILM COATED	100	18
63304-904-90	Valacyclovir	90 in 1 BOTTLE	TABLET, FILM COATED	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-904-30	EA - Each	63304-904	1efc89df-2709-448c-9c50-fd5989a6979c	1	2012-07-24
63304-904-90	EA - Each	63304-904	676d2473-e034-4fd2-bac0-113dd11d2c4e	1	2021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-904	VALACYCLOVIR TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	17	Current NDC, Legacy NDC, 6 package rows	20231130_26634bf1-c6d8-4d48-9a4e-845c47df07f8.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313564	valACYclovir 1 GM Oral Tablet	PSN	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313565	valACYclovir 500 MG Oral Tablet	PSN	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313564	valacyclovir 1000 MG Oral Tablet	SCD	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313565	valacyclovir 500 MG Oral Tablet	SCD	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313564	valacyclovir 1 GM Oral Tablet	SY	26634bf1-c6d8-4d48-9a4e-845c47df07f8	18
313564	valACYclovir 1 GM Oral Tablet	PSN	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313565	valACYclovir 500 MG Oral Tablet	PSN	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313565	valacyclovir 500 MG Oral Tablet	SCD	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	e3b4757b-d97b-6714-e053-2995a90a64eb	4
313564	valacyclovir 1 GM Oral Tablet	SY	e3b4757b-d97b-6714-e053-2995a90a64eb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-904-05	63304090405	500 TABLET, FILM COATED in 1 BOTTLE (63304-904-05)	2020-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir	Golden State Medical Supply, Inc.	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	5
Valacyclovir	SUN PHARMACEUTICAL INDUSTRIES, INC. \| Ohm Laboratories Inc.	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	19