Acyclovir

Product NDC: 10544-039
11-digit product format: 105440039
Labeler code: 10544
Product ID: 10544-039_f41aa20a-8824-477e-8f04-69760ba1197e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA074980
Marketing category: ANDA
Marketing start: 2011-03-02
Marketing end: 0000-00-00
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: E
Listing certified through: 2017-12-31
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	10544-039		I	Inactivated by FDA	2026-08-10
excluded package	package	10544-039	10544-039-25	I	Inactivated by FDA	2026-08-10
excluded package	package	10544-039	10544-039-40	I	Inactivated by FDA	2026-08-10

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 · 66 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	10544-039-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-039-40	`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	10544-039-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-039-40	`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	10544-039-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-039-40	`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	10544-039-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-039-40	`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	10544-039-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-039-40	`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	10544-039-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-039-40	`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	10544-039-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-039-40	`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	10544-039-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-039-40	`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	10544-039-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-039-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-039-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-039-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-039-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-039-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-039-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-039-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-039-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-039-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-039-25	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-039-40	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-039-25	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-039-40	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-039-25	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-039-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-039-25	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-039-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-039-25	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-039-40	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-039-25	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-039-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-039-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-039-40	`e2bbac7714bc…`	`27bdfed8d636…`

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
A074980-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL			1998-09-30
A074980-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL			1998-09-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074980-001	ACYCLOVIR	400MG	TABLET / ORAL	1998-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074980-002	ACYCLOVIR	800MG	TABLET / ORAL	1998-09-30	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33190c02-82e1-0a4d-d716-9ccd23588463	Product name	5	20250225
c367d1da-5a72-8966-6d11-1eb9a73ae758	Product name	3	20231115
5518bf13-db2f-2e9c-3679-e70ecf03752c	Product name	9	20210614
27897900-0e40-497b-97e1-88057e68fe6c	Product name	4	20200710
ca834e59-e669-229c-9288-0ccb76dc373e	Product name	9	20200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28	Product name	1	20190702
fb15b394-3715-4c87-a447-421489aa8739	Product name	3	20170727
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-039-25	2020-01-31	C162847	48780-1	9d75b9d0-5a52-f424-e053-dadaa90a57ce	Acyclovir Capsules, USP and Acyclovir Tablets, USP Rx only
10544-039-40	2020-01-31	C162847	48780-1	9d75b9d0-5a52-f424-e053-dadaa90a57ce	Acyclovir Capsules, USP and Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-039-25	Acyclovir	25 in 1 BOTTLE	TABLET	25		1
10544-039-40	Acyclovir	40 in 1 BOTTLE	TABLET	40		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-039-25	EA - Each	10544-039	52aa45b3-537a-4dc5-88e2-669a9d60acaa	1	2015-10-02
10544-039-40	EA - Each	10544-039	462579c0-33ba-452e-9cb7-e88a593b346a	1	2015-10-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-039	ACYCLOVIR CAPSULE ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20160609_f41aa20a-8824-477e-8f04-69760ba1197e.zip

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
197310	acyclovir 200 MG Oral Capsule	PSN	f41aa20a-8824-477e-8f04-69760ba1197e	1
197311	acyclovir 400 MG Oral Tablet	PSN	f41aa20a-8824-477e-8f04-69760ba1197e	1
197310	acyclovir 200 MG Oral Capsule	SCD	f41aa20a-8824-477e-8f04-69760ba1197e	1
197311	acyclovir 400 MG Oral Tablet	SCD	f41aa20a-8824-477e-8f04-69760ba1197e	1
197310	acycycloguanosine 200 MG Oral Capsule	SY	f41aa20a-8824-477e-8f04-69760ba1197e	1
197311	acycycloguanosine 400 MG Oral Tablet	SY	f41aa20a-8824-477e-8f04-69760ba1197e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-039-25	10544003925	25 in 1 BOTTLE	Historical
10544-039-40	10544003940	40 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Capsules, USP and Acyclovir Tablets, USP Rx only	Blenheim Pharmacal, Inc.	2015-03-12	HUMAN PRESCRIPTION DRUG LABEL	1