Valacyclovir Hydrochloride

Product NDC: 55111-553
11-digit product format: 551110553
Labeler code: 55111
Product ID: 55111-553_dc8ac169-4a86-0c1f-c57a-2bc68f6c2e9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddys Laboratories Limited
Application: ANDA079012
Marketing category: ANDA
Marketing start: 2010-12-06
Marketing end: 0000-00-00
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: 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	55111-553		I	Inactivated by FDA	2026-08-11
excluded package	package	55111-553	55111-553-01	D	Discontinued by firm	2026-08-11
excluded package	package	55111-553	55111-553-05	D	Discontinued by firm	2026-08-11
excluded package	package	55111-553	55111-553-30	D	Discontinued by firm	2026-08-11
excluded package	package	55111-553	55111-553-78	D	Discontinued by firm	2026-08-11
excluded package	package	55111-553	55111-553-90	D	Discontinued by firm	2026-08-11

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 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-553-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-553-78	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-553-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-553-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-553-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-553-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-553-78	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-553-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-553-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-553-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-553-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-553-78	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-553-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-553-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-553-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-553-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-553-78	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-553-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-553-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-553-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-553-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-553-78	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-553-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-553-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-553-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-553-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-553-78	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-553-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-553-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-553-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-553-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-553-78	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-553-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-553-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-553-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-553-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-553-78	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-553-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-553-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-553-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-553-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-553-78	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-553-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-553-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-553-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-553-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-553-78	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-553-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-553-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-553-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

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
A079012-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2010-05-24
A079012-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB		2010-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079012-001	AB
A079012-002	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	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079012-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079012-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`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	A079012-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079012-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079012-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079012-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079012-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079012-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079012-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079012-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079012-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079012-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079012-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079012-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079012-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079012-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079012-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079012-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079012-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079012-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079012-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079012-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079012-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079012-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079012-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079012-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079012-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079012-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079012-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079012-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079012-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079012-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079012-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079012-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079012-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079012-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079012-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079012-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079012-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079012-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079012-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079012-002	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, Related label table
NDC	Related label
55111-553-01	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 for oral use Initial U.S. Approval: 1995
55111-553-05	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 for oral use Initial U.S. Approval: 1995
55111-553-30	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 for oral use Initial U.S. Approval: 1995
55111-553-78	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 for oral use Initial U.S. Approval: 1995
55111-553-90	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 for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-553-01	Valacyclovir Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
55111-553-05	Valacyclovir Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
55111-553-30	Valacyclovir Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
55111-553-78	Valacyclovir Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	11
55111-553-79	Valacyclovir Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	11
55111-553-90	Valacyclovir Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-553-05	EA - Each	55111-553	ba5eeb69-252c-4e4e-86e8-d55073023d2d	1	2012-07-24
55111-553-30	EA - Each	55111-553	b8b9a0f4-feff-4ec4-8469-aa6889eb71ee	1	2012-07-24
55111-553-90	EA - Each	55111-553	55882307-5e66-4e79-bf99-c52f71afb892	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
valacyclovir	ACTIVE INGREDIENT	MZ1IW7Q79D	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
valacyclovir	ACTIVE MOIETY	MZ1IW7Q79D	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-553	VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]	11	Legacy NDC, 6 package rows	20190312_2d38cbdb-4e4d-4174-461d-7a3b6475e6a5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir Hydrochloride	VALACYCLOVIR HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	c33a2a36-16d3-4a35-e053-2995a90af240	2021-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079012 application number: ANDA079012

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	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313565	valACYclovir 500 MG Oral Tablet	PSN	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313564	valacyclovir 1000 MG Oral Tablet	SCD	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313565	valacyclovir 500 MG Oral Tablet	SCD	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313565	valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet	SY	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11
313564	valacyclovir 1 GM Oral Tablet	SY	2d38cbdb-4e4d-4174-461d-7a3b6475e6a5	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55111-553-01	55111055301	100 in 1 BOTTLE	Historical
55111-553-05	55111055305	500 in 1 BOTTLE	Historical
55111-553-30	55111055330	30 in 1 BOTTLE	Historical
55111-553-78	55111055378	10 in 1 CARTON	Historical
55111-553-79	55111055379	10 in 1 BLISTER PACK	Historical
55111-553-90	55111055390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir Hydrochloride	Dr. Reddys Laboratories Limited \| Dr. Reddys Laboratories Limited-FTO 3	2018-12-18	HUMAN PRESCRIPTION DRUG LABEL	11