Acyclovir

Product NDC: 68071-2501
Requested package NDC: 68071-2501-4
11-digit product format: 680712501
Labeler code: 68071
Product ID: 68071-2501_c94d0ed2-77bc-7c0d-e053-2a95a90a8b00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA075382
Marketing category: ANDA
Marketing start: 2009-10-22
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2501	68071-2501-4	D	Discontinued by firm		2026-08-11

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A075382-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		1999-04-30
A075382-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075382-001	AB
A075382-002	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	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`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	A075382-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075382-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075382-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075382-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075382-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075382-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075382-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075382-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075382-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075382-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075382-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075382-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075382-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075382-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075382-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075382-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075382-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075382-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2501-4	2023-01-30	C162847	48780-1	f386c649-d0a7-0266-e053-dadaa90a7c1a	Acyclovir Tablets USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2501	ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20210812_c94d68df-a80d-1d52-e053-2a95a90aa8d7.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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Cardinal Health 107, LLC	d8004652-86fe-4714-81d4-5e1dd2585bb4	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	AvPAK	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f3cbd634-77c8-3306-bdbd-a4598b20603e	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e0f17e6f-63c7-4828-8585-91fc582df30b	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8c5d1f30-2d31-417d-860b-7228b7baaa64	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	89583890-186b-4a7a-8741-41f6c5f0a99d	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	a68e610a-841c-4b69-9233-673d060561e8	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c46d5033-b1b2-e213-e053-2995a90ae6a3	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Proficient Rx LP	33630a35-346e-43b6-9286-89e28ac0094a	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2501-4	68071250104	4 TABLET in 1 BOTTLE, PLASTIC (68071-2501-4)	4 tablet	2021-08-11	0000-00-00	No	No	Current