Valacyclovir

Product NDC: 68071-4805
11-digit product format: 680714805
Labeler code: 68071
Product ID: 68071-4805_4f70a224-a1fa-2b68-e063-6394a90a38bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203047
Marketing category: ANDA
Marketing start: 2015-05-25
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	68071-4805		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4805	68071-4805-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A203047-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2015-04-08
A203047-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	RS	2015-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203047-001	AB
A203047-002	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	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`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	A203047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203047-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203047-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203047-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203047-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203047-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203047-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203047-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203047-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203047-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203047-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203047-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203047-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203047-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203047-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203047-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203047-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G447S0T1VC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313564	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
84601168-8829-f4a3-e053-2991aa0a3c20	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#

Effective, Related label table
Effective	Related label
2024-03-21	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
2023-01-30	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
2021-02-17	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
2021-01-29	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-4805-1	Valacyclovir	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
68071-4805-3	Valacyclovir	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
68071-4805-6	Valacyclovir	60 in 1 BOTTLE	TABLET, FILM COATED	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4805	VALACYCLOVIR TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240616_84601168-8829-f4a3-e053-2991aa0a3c20.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	7c332401-afb6-455b-b61a-ea108a377ef6	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	St Mary's Medical Park Pharmacy	bed99bed-3904-5278-e053-2a95a90aeab6	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	1b11361c-5444-498b-ab7c-fbad917705ae	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Coupler LLC	5100ef9f-6dc2-fa06-e063-6294a90accd0	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Coupler LLC	50237c2d-99e8-9899-e063-6394a90a468c	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals,Inc.	84601168-8829-f4a3-e053-2991aa0a3c20	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047 ndc (product): 68071-4805
Valacyclovir	VALACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e6f54a83-eb07-49d6-b93a-6fe94db323b8	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	69301126-c901-4d0d-9acb-91ba1a87cd21	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	4ab809f3-8898-463c-b55a-f452c87d0779	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Quallent Pharmaceuticals Health LLC	764b0cf9-9207-404c-87a8-a1e0109af6cc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Camber Pharmaceuticals, Inc.	7f5e96e0-534c-47a5-bb79-926088afc73c	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals, Inc.	7abc96b9-8f34-4fda-b5bb-1bdf23c1e135	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	296c04dc-2c64-4784-e063-6294a90ae6a3	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	2c2d5cec-038f-42bb-8f04-90d2431dc1c9	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	3aff1f5e-d92b-686b-e063-6294a90a2995	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	90a67c02-edce-44aa-8d3a-d819313acc26	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	29a6b4ec-3e23-289b-e063-6394a90a1157	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	e5f5223f-569c-40c6-a3c7-381bc61cf8c6	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	8794a786-245a-42a3-b33a-9b0ed1dd46ac	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047

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	84601168-8829-f4a3-e053-2991aa0a3c20	5
313564	valacyclovir 1000 MG Oral Tablet	SCD	84601168-8829-f4a3-e053-2991aa0a3c20	5
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	84601168-8829-f4a3-e053-2991aa0a3c20	5
313564	valacyclovir 1 GM Oral Tablet	SY	84601168-8829-f4a3-e053-2991aa0a3c20	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4805-1	68071480501	90 TABLET, FILM COATED in 1 BOTTLE (68071-4805-1)	2019-03-18	0000-00-00	No	No	Current
68071-4805-3	68071480503	30 TABLET, FILM COATED in 1 BOTTLE (68071-4805-3)	2026-04-14		No	No	Current
68071-4805-6	68071480506	60 TABLET, FILM COATED in 1 BOTTLE (68071-4805-6)	2019-03-18		No	No	Current