Acyclovir

Product NDC: 71335-0323
11-digit product format: 713350323
Labeler code: 71335
Product ID: 71335-0323_e20bedec-0eb8-4d24-9148-a3ece431dcba
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: 400 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

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 · 165 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	71335-0323-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0323-8	`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	71335-0323-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0323-8	`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	71335-0323-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0323-8	`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	71335-0323-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0323-8	`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	71335-0323-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0323-8	`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	71335-0323-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0323-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0323-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0323-5	`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	400 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
197311	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
0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
71335-0323-0	Acyclovir Tablets, USP Rx only
71335-0323-1	Acyclovir Tablets, USP Rx only
71335-0323-2	Acyclovir Tablets, USP Rx only
71335-0323-3	Acyclovir Tablets, USP Rx only
71335-0323-4	Acyclovir Tablets, USP Rx only
71335-0323-5	Acyclovir Tablets, USP Rx only
71335-0323-6	Acyclovir Tablets, USP Rx only
71335-0323-7	Acyclovir Tablets, USP Rx only
71335-0323-8	Acyclovir Tablets, USP Rx only
71335-0323-9	Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0323-0	Acyclovir	120 in 1 BOTTLE	TABLET	120	8
71335-0323-1	Acyclovir	20 in 1 BOTTLE	TABLET	20	8
71335-0323-2	Acyclovir	28 in 1 BOTTLE	TABLET	28	8
71335-0323-3	Acyclovir	30 in 1 BOTTLE	TABLET	30	8
71335-0323-4	Acyclovir	50 in 1 BOTTLE	TABLET	50	8
71335-0323-5	Acyclovir	15 in 1 BOTTLE	TABLET	15	8
71335-0323-6	Acyclovir	60 in 1 BOTTLE	TABLET	60	8
71335-0323-7	Acyclovir	25 in 1 BOTTLE	TABLET	25	8
71335-0323-8	Acyclovir	10 in 1 BOTTLE	TABLET	10	8
71335-0323-9	Acyclovir	40 in 1 BOTTLE	TABLET	40	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0323-0	EA - Each	71335-0323	f7973139-e1e1-417b-9696-708afb07c365	1	2018-01-12
71335-0323-1	EA - Each	71335-0323	e70be971-86e8-4199-946f-fbbad153c031	1	2018-01-12
71335-0323-2	EA - Each	71335-0323	c5517d29-e074-401b-a9a2-0d9e64c5c87f	1	2018-01-12
71335-0323-3	EA - Each	71335-0323	8cc0e0ec-cd8c-46fc-8baa-f9164d65bd1d	1	2018-01-12
71335-0323-4	EA - Each	71335-0323	8da5b790-5a3e-488d-9442-2f200d123f51	1	2018-01-12
71335-0323-5	EA - Each	71335-0323	0ab4b4c2-6040-4f89-b55a-ace1cc4fdf8a	1	2018-01-12
71335-0323-6	EA - Each	71335-0323	032c4602-d34d-4a8e-abe5-d789b2ddaf5f	1	2018-01-12
71335-0323-7	EA - Each	71335-0323	ee48e8be-8727-4e9f-8f28-bcbc0df41287	1	2018-01-12
71335-0323-8	EA - Each	71335-0323	bce20f9f-25a2-4c0b-bcd4-73fac40ca481	1	2018-01-12
71335-0323-9	EA - Each	71335-0323	6cf2c4c3-5152-4d49-bb56-e5dfceb25a9a	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0323	ACYCLOVIR (ACYCLOVIR) TABLET [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 10 package rows	20220125_0e78d5e8-ae2d-4e84-b8c2-6765b1299c12.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
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 ndc (product): 71335-0323
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
197311	acyclovir 400 MG Oral Tablet	PSN	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	8
197311	acyclovir 400 MG Oral Tablet	SCD	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	8
197311	acycycloguanosine 400 MG Oral Tablet	SY	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0323-0	71335032300	120 TABLET in 1 BOTTLE (71335-0323-0)	120 tablet	2018-05-02	0000-00-00	No	No	Current
71335-0323-1	71335032301	20 TABLET in 1 BOTTLE (71335-0323-1)	20 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0323-2	71335032302	28 TABLET in 1 BOTTLE (71335-0323-2)	28 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0323-3	71335032303	30 TABLET in 1 BOTTLE (71335-0323-3)	30 tablet	2018-03-20	0000-00-00	No	No	Current
71335-0323-4	71335032304	50 TABLET in 1 BOTTLE (71335-0323-4)	50 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0323-5	71335032305	15 TABLET in 1 BOTTLE (71335-0323-5)	15 tablet	2018-04-17	0000-00-00	No	No	Current
71335-0323-6	71335032306	60 TABLET in 1 BOTTLE (71335-0323-6)	60 tablet	2019-07-29	0000-00-00	No	No	Current
71335-0323-7	71335032307	25 TABLET in 1 BOTTLE (71335-0323-7)	25 tablet	2018-03-28	0000-00-00	No	No	Current
71335-0323-8	71335032308	10 TABLET in 1 BOTTLE (71335-0323-8)	10 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0323-9	71335032309	40 TABLET in 1 BOTTLE (71335-0323-9)	40 tablet	2021-12-27	0000-00-00	No	No	Current