Valacyclovir

Product NDC: 69367-263
11-digit product format: 693670263
Labeler code: 69367
Product ID: 69367-263_0d49baa9-8b27-4d4c-b57a-802a337565f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA209553
Marketing category: ANDA
Marketing start: 2023-02-14
Substance: VALACYCLOVIR HYDROCHLORIDE
Active strength: 1000 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: 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
A209553-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2020-03-18
A209553-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2020-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209553-001	AB
A209553-002	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 2 · 74 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	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209553-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2020-03-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209553-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2020-03-18	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A209553-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209553-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209553-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209553-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209553-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209553-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209553-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209553-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209553-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209553-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209553-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209553-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209553-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209553-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209553-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209553-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209553-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209553-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209553-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209553-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209553-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209553-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209553-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209553-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209553-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209553-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209553-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209553-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209553-002	AB	1	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	1000 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
4bd97421-1e0a-40a6-a66b-f5f14e827eb3	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	Strength	SPL version
69367-263-09	Valacyclovir	90 in 1 BOTTLE	TABLET	90		4
69367-263-30	Valacyclovir	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-263-09	EA - Each	69367-263	3bf95b9b-731c-47a0-b039-112d5404c557	1	2023-04-07
69367-263-30	EA - Each	69367-263	90cf3a81-e76e-49f1-8a99-9eb3b59da4b0	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-263	VALACYCLOVIR TABLET [WESTMINSTER PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20230301_4bd97421-1e0a-40a6-a66b-f5f14e827eb3.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	5e39bf80-ada6-4194-bf3d-2c044c3389da	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	6ff2068f-1002-4d84-bd65-081d5b4082b1	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Westminster Pharmaceuticals, LLC	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553 ndc (product): 69367-263
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	890f45c7-191b-4d60-8c52-ed92c2319eb3	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Redpharm Drug	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Yiling Pharmaceutical, Inc.	f3ee4017-a4fc-475d-a49b-b39168ec5966	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Chartwell RX, LLC	e59f15d0-c32a-4848-bdd5-fc2542e561c0	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Direct _Rx	26a43531-c62a-9e7f-e063-6394a90a8d3f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals Inc.	3146e367-8438-4141-9368-95ce6f59c724	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Direct_Rx	387c9c12-4735-1f9d-e063-6394a90a030c	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	65d13d0e-cf7f-4422-81f1-3dfce4722718	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	5af8f909-ad53-480e-9176-43f95dcc218a	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	b713ebfb-096e-445e-ab15-129aca20fadf	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	6719e877-cff4-4be8-a352-8df0afa4f74c	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals,Inc.	1ac7a13e-3f30-e140-e063-6394a90aa09d	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	a3a6a874-f568-429d-96b4-8ef89393564f	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	659a7c36-378a-4392-bb13-948337caf17f	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209553 application number: ANDA209553

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	5e39bf80-ada6-4194-bf3d-2c044c3389da	9
313564	valacyclovir 1000 MG Oral Tablet	SCD	5e39bf80-ada6-4194-bf3d-2c044c3389da	9
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	5e39bf80-ada6-4194-bf3d-2c044c3389da	9
313564	valacyclovir 1 GM Oral Tablet	SY	5e39bf80-ada6-4194-bf3d-2c044c3389da	9
313564	valACYclovir 1 GM Oral Tablet	PSN	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	5
313564	valacyclovir 1000 MG Oral Tablet	SCD	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	5
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	5
313564	valacyclovir 1 GM Oral Tablet	SY	3251a0f1-cbfd-c9d6-e063-6394a90a09a0	5
313564	valACYclovir 1 GM Oral Tablet	PSN	26a43531-c62a-9e7f-e063-6394a90a8d3f	4
313564	valACYclovir 1 GM Oral Tablet	PSN	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313565	valACYclovir 500 MG Oral Tablet	PSN	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir 1000 MG Oral Tablet	SCD	26a43531-c62a-9e7f-e063-6394a90a8d3f	4
313565	valacyclovir 500 MG Oral Tablet	SCD	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	26a43531-c62a-9e7f-e063-6394a90a8d3f	4
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir 1 GM Oral Tablet	SY	4bd97421-1e0a-40a6-a66b-f5f14e827eb3	4
313564	valacyclovir 1 GM Oral Tablet	SY	26a43531-c62a-9e7f-e063-6394a90a8d3f	4
313564	valACYclovir 1 GM Oral Tablet	PSN	3146e367-8438-4141-9368-95ce6f59c724	2
313564	valACYclovir 1 GM Oral Tablet	PSN	a3a6a874-f568-429d-96b4-8ef89393564f	2
313565	valACYclovir 500 MG Oral Tablet	PSN	a3a6a874-f568-429d-96b4-8ef89393564f	2
313564	valacyclovir 1000 MG Oral Tablet	SCD	3146e367-8438-4141-9368-95ce6f59c724	2
313564	valacyclovir 1000 MG Oral Tablet	SCD	a3a6a874-f568-429d-96b4-8ef89393564f	2
313565	valacyclovir 500 MG Oral Tablet	SCD	a3a6a874-f568-429d-96b4-8ef89393564f	2
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	3146e367-8438-4141-9368-95ce6f59c724	2
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	a3a6a874-f568-429d-96b4-8ef89393564f	2
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	a3a6a874-f568-429d-96b4-8ef89393564f	2
313564	valacyclovir 1 GM Oral Tablet	SY	3146e367-8438-4141-9368-95ce6f59c724	2
313564	valacyclovir 1 GM Oral Tablet	SY	a3a6a874-f568-429d-96b4-8ef89393564f	2
313564	valACYclovir 1 GM Oral Tablet	PSN	5af8f909-ad53-480e-9176-43f95dcc218a	1
313564	valACYclovir 1 GM Oral Tablet	PSN	b713ebfb-096e-445e-ab15-129aca20fadf	1
313564	valACYclovir 1 GM Oral Tablet	PSN	1ac7a13e-3f30-e140-e063-6394a90aa09d	1
313564	valACYclovir 1 GM Oral Tablet	PSN	6719e877-cff4-4be8-a352-8df0afa4f74c	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	b713ebfb-096e-445e-ab15-129aca20fadf	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	5af8f909-ad53-480e-9176-43f95dcc218a	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	6719e877-cff4-4be8-a352-8df0afa4f74c	1
313564	valacyclovir 1000 MG Oral Tablet	SCD	1ac7a13e-3f30-e140-e063-6394a90aa09d	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	6719e877-cff4-4be8-a352-8df0afa4f74c	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	5af8f909-ad53-480e-9176-43f95dcc218a	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	1ac7a13e-3f30-e140-e063-6394a90aa09d	1
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	b713ebfb-096e-445e-ab15-129aca20fadf	1
313564	valacyclovir 1 GM Oral Tablet	SY	6719e877-cff4-4be8-a352-8df0afa4f74c	1
313564	valacyclovir 1 GM Oral Tablet	SY	5af8f909-ad53-480e-9176-43f95dcc218a	1
313564	valacyclovir 1 GM Oral Tablet	SY	1ac7a13e-3f30-e140-e063-6394a90aa09d	1
313564	valacyclovir 1 GM Oral Tablet	SY	b713ebfb-096e-445e-ab15-129aca20fadf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69367-263-09	69367026309	90 TABLET in 1 BOTTLE (69367-263-09)	90 tablet	2023-02-14	No	No	Current
69367-263-30	69367026330	30 TABLET in 1 BOTTLE (69367-263-30)	30 tablet	2023-02-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir	REMEDYREPACK INC.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	11
Valacyclovir	Westminster Pharmaceuticals, LLC	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	4
Valacyclovir	Redpharm Drug	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	5
Valacyclovir	Direct _Rx \| Direct_Rx	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	4
Valacyclovir	Preferred Pharmaceuticals Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	2
Valacyclovir	A-S Medication Solutions	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	1
Valacyclovir	Bryant Ranch Prepack	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	1
Valacyclovir	A-S Medication Solutions	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Valacyclovir	NuCare Pharmaceuticals,Inc.	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
Valacyclovir	Proficient Rx LP	2023-12-01	HUMAN PRESCRIPTION DRUG LABEL	2