Valacyclovir Hydrochloride

Product NDC: 0781-5209
11-digit product format: 007815209
Labeler code: 0781
Product ID: 0781-5209_7ad950ff-aaff-4da0-b1ae-403d86fb06a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc.
Application: ANDA077478
Marketing category: ANDA
Marketing start: 2010-05-24
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5209		D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-01	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-05	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-13	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-27	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-31	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5209	0781-5209-92	D	Discontinued by firm	2026-08-17

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 · 77 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	0781-5209-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5209-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5209-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5209-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5209-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5209-05	`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	0781-5209-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5209-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5209-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5209-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5209-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5209-05	`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	0781-5209-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5209-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5209-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5209-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5209-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5209-05	`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	0781-5209-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5209-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5209-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5209-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5209-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5209-05	`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	0781-5209-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5209-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5209-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5209-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5209-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5209-05	`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	0781-5209-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5209-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5209-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5209-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5209-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5209-05	`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	0781-5209-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5209-27	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5209-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5209-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5209-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5209-05	`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	0781-5209-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5209-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5209-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5209-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5209-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5209-05	`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	0781-5209-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5209-27	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5209-13	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077478-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL			2010-05-24
A077478-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL			2010-05-24

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 · 84 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
2026-08-18 06:07:40	2026-07	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-001	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	A077478-002	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	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL		2010-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-001	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	A077478-002	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	A077478-001	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	A077478-002	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	A077478-001	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	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077478-002	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	A077478-001	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	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077478-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077478-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2010-05-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077478-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077478-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077478-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077478-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077478-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077478-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077478-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077478-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077478-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077478-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077478-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077478-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077478-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077478-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077478-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077478-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077478-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077478-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077478-002	AB	1	`1c564ffb4f44…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5209-31	EA - Each	0781-5209	51595c09-ceb2-4d62-b858-1673e5e91257	1	2012-07-24
0781-5209-92	EA - Each	0781-5209	0b543768-3b28-4f06-b186-de3f136e8084	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC]	5
VALACYCLOVIR HYDROCHLORIDE	ACTIVE INGREDIENT	G447S0T1VC	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE	124832-27-5	VALACYCLOVIR HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5209-01	00781520901	100 TABLET in 1 BOTTLE (0781-5209-01)	100 tablet	2010-05-24	0000-00-00	No	No	Current
0781-5209-05	00781520905	500 TABLET in 1 BOTTLE (0781-5209-05)	500 tablet	2010-05-24	0000-00-00	No	No	Current
0781-5209-13	00781520913	100 TABLET in 1 BOX, UNIT-DOSE (0781-5209-13)	100 tablet	2010-05-24	0000-00-00	No	No	Current
0781-5209-27	00781520927	21 TABLET in 1 BOTTLE (0781-5209-27)	21 tablet	2010-05-24	0000-00-00	No	No	Current
0781-5209-31	00781520931	30 TABLET in 1 BOTTLE (0781-5209-31)	30 tablet	2010-05-24	0000-00-00	No	No	Current
0781-5209-92	00781520992	90 TABLET in 1 BOTTLE (0781-5209-92)	90 tablet	2010-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valacyclovir Hydrochloride	Sandoz Inc.	2021-06-22	HUMAN PRESCRIPTION DRUG LABEL	8
Valacyclovir	Direct Rx	2016-06-22	HUMAN PRESCRIPTION DRUG LABEL	4