valacyclovir hydrochloride

Product NDC: 67296-1076
Requested package NDC: 67296-1076-1
11-digit product format: 672961076
Labeler code: 67296
Product ID: 67296-1076_b8d064ea-f36e-569d-e053-2995a90ab730
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA201506
Marketing category: ANDA
Marketing start: 2019-01-01
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1076	67296-1076-1	I	Inactivated by FDA		2026-08-07

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`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	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…`
2021-12-28 21:50 UTC	2021-12	A201506-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201506-002	AB	1	`782e0a99824c…`

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
67296-1076-1	2023-01-30	C162847	48780-1	f386c64a-1e10-0266-e053-dadaa90a7c1a	valacyclovir 1gm
67296-1076-6	2023-01-30	C162847	48780-1	f386c64a-1e10-0266-e053-dadaa90a7c1a	valacyclovir 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1076-1	valacyclovir hydrochloride	21 in 1 BOTTLE	TABLET, FILM COATED	21		6
67296-1076-6	valacyclovir hydrochloride	6 in 1 BOTTLE	TABLET, FILM COATED	6		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1076	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]	6	Legacy NDC, 2 package rows	20210114_8853428e-2690-1ef6-e053-2a95a90a0a4b.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
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	8853428e-2690-1ef6-e053-2a95a90a0a4b	6
313564	valacyclovir 1000 MG Oral Tablet	SCD	8853428e-2690-1ef6-e053-2a95a90a0a4b	6
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	8853428e-2690-1ef6-e053-2a95a90a0a4b	6
313564	valacyclovir 1 GM Oral Tablet	SY	8853428e-2690-1ef6-e053-2a95a90a0a4b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1076-1	67296107601	21 TABLET, FILM COATED in 1 BOTTLE (67296-1076-1)	2019-01-01	0000-00-00	No	No	Current