Valacyclovir

Product NDC: 68071-3135
11-digit product format: 680713135
Labeler code: 68071
Product ID: 68071-3135_bb13437d-35ff-fdff-e053-2995a90aff8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203047
Marketing category: ANDA
Marketing start: 2015-05-25
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-3135		D	Discontinued by firm	2026-08-03
excluded package	package	68071-3135	68071-3135-1	D	Discontinued by firm	2026-08-03
excluded package	package	68071-3135	68071-3135-3	D	Discontinued by firm	2026-08-03

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 · 45 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3135-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3135-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3135-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3135-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3135-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3135-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3135-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3135-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3135-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3135-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3135-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3135-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3135-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3135-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3135-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3135-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3135-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3135-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3135-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-3135-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3135-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-3135-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3135-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3135-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3135-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3135-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3135-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3135-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3135-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3135-3	I	Inactivated by FDA	`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
A203047-001	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB		2015-04-08
A203047-002	VALACYCLOVIR HYDROCHLORIDE	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	RS	2015-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203047-001	AB
A203047-002	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	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203047-001	VALACYCLOVIR HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2015-04-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203047-002	VALACYCLOVIR HYDROCHLORIDE	EQ 1GM BASE	TABLET / ORAL	AB	2015-04-08	`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	A203047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203047-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203047-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203047-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203047-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203047-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203047-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203047-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203047-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203047-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203047-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203047-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203047-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203047-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203047-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203047-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203047-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203047-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203047-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203047-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203047-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203047-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203047-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203047-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203047-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203047-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203047-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203047-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3135-1	2024-07-19	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-3	2024-07-19	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-1	2023-01-30	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-3	2023-01-30	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-1	2021-02-11	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-3	2021-02-11	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-1	2021-01-29	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995
68071-3135-3	2021-01-29	HIGHLIGHTS OF PRESCRIBING INFORMATION 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 Initial U.S. Approval:1995

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	7c332401-afb6-455b-b61a-ea108a377ef6	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	St Mary's Medical Park Pharmacy	bed99bed-3904-5278-e053-2a95a90aeab6	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	1b11361c-5444-498b-ab7c-fbad917705ae	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Coupler LLC	5100ef9f-6dc2-fa06-e063-6294a90accd0	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Coupler LLC	50237c2d-99e8-9899-e063-6394a90a468c	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals,Inc.	84601168-8829-f4a3-e053-2991aa0a3c20	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e6f54a83-eb07-49d6-b93a-6fe94db323b8	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	69301126-c901-4d0d-9acb-91ba1a87cd21	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	A-S Medication Solutions	4ab809f3-8898-463c-b55a-f452c87d0779	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Quallent Pharmaceuticals Health LLC	764b0cf9-9207-404c-87a8-a1e0109af6cc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Camber Pharmaceuticals, Inc.	7f5e96e0-534c-47a5-bb79-926088afc73c	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Preferred Pharmaceuticals, Inc.	7abc96b9-8f34-4fda-b5bb-1bdf23c1e135	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	296c04dc-2c64-4784-e063-6294a90ae6a3	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	REMEDYREPACK INC.	2c2d5cec-038f-42bb-8f04-90d2431dc1c9	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	3aff1f5e-d92b-686b-e063-6294a90a2995	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	90a67c02-edce-44aa-8d3a-d819313acc26	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	NuCare Pharmaceuticals, Inc.	29a6b4ec-3e23-289b-e063-6394a90a1157	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Bryant Ranch Prepack	e5f5223f-569c-40c6-a3c7-381bc61cf8c6	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047
Valacyclovir	VALACYCLOVIR	Proficient Rx LP	8794a786-245a-42a3-b33a-9b0ed1dd46ac	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203047 application number: ANDA203047

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3135-1	68071313501	21 TABLET, FILM COATED in 1 BOTTLE (68071-3135-1)	2017-02-28	0000-00-00	No	No	Current
68071-3135-3	68071313503	30 TABLET, FILM COATED in 1 BOTTLE (68071-3135-3)	2017-02-28	0000-00-00	No	No	Current