valacyclovir hydrochloride

Product NDC: 50436-3240
11-digit product format: 504363240
Labeler code: 50436
Product ID: 50436-3240_3fe8910f-3902-494d-81f5-e45c36f84fdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA201506
Marketing category: ANDA
Marketing start: 2012-04-05
Marketing end: 0000-00-00
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: 2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-3240		I	Inactivated by FDA	2026-10-05
excluded package	package	50436-3240	50436-3240-1	I	Inactivated by FDA	2026-10-05
excluded package	package	50436-3240	50436-3240-3	I	Inactivated by FDA	2026-10-05
excluded package	package	50436-3240	50436-3240-4	I	Inactivated by FDA	2026-10-05
excluded package	package	50436-3240	50436-3240-5	I	Inactivated by FDA	2026-10-05
excluded package	package	50436-3240	50436-3240-6	I	Inactivated by FDA	2026-10-05

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 2 · 114 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-3240-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-3240-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-3240-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-3240-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-3240-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-3240-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-3240-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-3240-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-3240-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-3240-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3240-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3240-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3240-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3240-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-3240-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3240-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3240-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3240-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3240-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-3240-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3240-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3240-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3240-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3240-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-3240-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3240-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3240-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3240-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3240-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-3240-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3240-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3240-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3240-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3240-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-3240-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3240-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3240-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3240-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3240-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-3240-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3240-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3240-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3240-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3240-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-3240-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3240-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3240-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3240-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3240-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3240-3	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A201506-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2012-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201506-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2012-04-03	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201506-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201506-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201506-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201506-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201506-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201506-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201506-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201506-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201506-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201506-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201506-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201506-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201506-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201506-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201506-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201506-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201506-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201506-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201506-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201506-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201506-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201506-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201506-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201506-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201506-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201506-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201506-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201506-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201506-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201506-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201506-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201506-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201506-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201506-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201506-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201506-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
50436-3240-1	These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
50436-3240-3	These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
50436-3240-4	These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
50436-3240-5	These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
50436-3240-6	These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-3240-1	valacyclovir hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
50436-3240-3	valacyclovir hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
50436-3240-4	valacyclovir hydrochloride	12 in 1 BOTTLE	TABLET, FILM COATED	12	4
50436-3240-5	valacyclovir hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	4
50436-3240-6	valacyclovir hydrochloride	24 in 1 BOTTLE	TABLET, FILM COATED	24	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3240	VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	4	Legacy NDC, 5 package rows	20190307_ad17b820-e9b9-407b-94e1-614073feb6dd.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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-3240-1	50436324001	30 in 1 BOTTLE	Historical
50436-3240-3	50436324003	90 in 1 BOTTLE	Historical
50436-3240-4	50436324004	12 in 1 BOTTLE	Historical
50436-3240-5	50436324005	15 in 1 BOTTLE	Historical
50436-3240-6	50436324006	24 in 1 BOTTLE	Historical