Acyclovir

Product NDC: 71335-0695
11-digit product format: 713350695
Labeler code: 71335
Product ID: 71335-0695_b4baef46-4b41-48c0-98c3-27068950a018
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203834
Marketing category: ANDA
Marketing start: 2013-11-29
Substance: ACYCLOVIR
Active strength: 800 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: 2027-12-31
Current FDA listing: Yes

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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0695		D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-0	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-1	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-2	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-3	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-4	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-5	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-6	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-7	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-8	D	Discontinued by firm	2026-10-05
excluded package	package	71335-0695	71335-0695-9	D	Discontinued by firm	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 3 · 132 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	71335-0695-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0695-8	`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	71335-0695-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0695-8	`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	71335-0695-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0695-8	`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	71335-0695-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0695-8	`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	71335-0695-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0695-8	`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	71335-0695-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0695-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0695-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0695-0	`cdf11ea48f46…`	`ba0047e9e063…`

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
A203834-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29
A203834-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203834-001	AB
A203834-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203834-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203834-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203834-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203834-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Acyclovir
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4HES1O11F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197313	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0695-0	Acyclovir	500 in 1 BOTTLE	TABLET	500	102
71335-0695-1	Acyclovir	25 in 1 BOTTLE	TABLET	25	102
71335-0695-2	Acyclovir	35 in 1 BOTTLE	TABLET	35	102
71335-0695-3	Acyclovir	30 in 1 BOTTLE	TABLET	30	102
71335-0695-4	Acyclovir	60 in 1 BOTTLE	TABLET	60	102
71335-0695-5	Acyclovir	50 in 1 BOTTLE	TABLET	50	102
71335-0695-6	Acyclovir	10 in 1 BOTTLE	TABLET	10	102
71335-0695-7	Acyclovir	40 in 1 BOTTLE	TABLET	40	102
71335-0695-8	Acyclovir	21 in 1 BOTTLE	TABLET	21	102
71335-0695-9	Acyclovir	90 in 1 BOTTLE	TABLET	90	102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0695	ACYCLOVIR (ACYCLOVIR) TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 10 package rows	20240820_dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals, Inc.	5176c7f9-9076-4797-e054-00144ff8d46c	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	6d0e492e-5359-49e8-812d-8c8e2e5d42f8	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	736679be-469e-4bdb-8e15-b10751c3dd60	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	38547daa-7d2f-4a7b-84d3-6e164984f958	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834 ndc (product): 71335-0695
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Major Pharmaceuticals	46150f19-ce5d-42a0-80a7-f96fda2b9879	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals, Inc.	b6d69697-12bb-4548-a6c3-2463cbf54f8f	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Camber Pharmaceuticals, Inc.	0910335b-6796-459f-b97e-d7ef5439a060	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	5dcfd21c-43f0-469c-be70-a4e74e6ccf88	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	f6f56143-ea74-af87-e053-6394a90ae346	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Advanced Rx Pharmacy of Tennessee, LLC	f4c5779d-e4bf-4f2b-e053-2995a90a9187	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	638803d2-a172-486d-e053-2991aa0ab074	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	83e82707-85b6-2fea-e053-2991aa0a99ef	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	A-S Medication Solutions	e4f91376-9e18-41a4-aa5e-adcea0c625d9	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	8fb01f23-e2bd-6850-e053-2995a90a7cc5	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197313	acyclovir 800 MG Oral Tablet	PSN	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102
197313	acyclovir 800 MG Oral Tablet	SCD	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102
197313	acycycloguanosine 800 MG Oral Tablet	SY	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0695-0	71335069500	500 TABLET in 1 BOTTLE (71335-0695-0)	500 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-1	71335069501	25 TABLET in 1 BOTTLE (71335-0695-1)	25 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-2	71335069502	35 TABLET in 1 BOTTLE (71335-0695-2)	35 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-3	71335069503	30 TABLET in 1 BOTTLE (71335-0695-3)	30 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-4	71335069504	60 TABLET in 1 BOTTLE (71335-0695-4)	60 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-5	71335069505	50 TABLET in 1 BOTTLE (71335-0695-5)	50 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-6	71335069506	10 TABLET in 1 BOTTLE (71335-0695-6)	10 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-7	71335069507	40 TABLET in 1 BOTTLE (71335-0695-7)	40 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-8	71335069508	21 TABLET in 1 BOTTLE (71335-0695-8)	21 tablet	2022-02-23	0000-00-00	No	No	Current
71335-0695-9	71335069509	90 TABLET in 1 BOTTLE (71335-0695-9)	90 tablet	2022-02-23	0000-00-00	No	No	Current