acyclovir

Product NDC: 67296-1034
Requested package NDC: 67296-1034-3
11-digit product format: 672961034
Labeler code: 67296
Product ID: 67296-1034_d60f9a37-90c2-7879-e053-2995a90a4d55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA077309
Marketing category: ANDA
Marketing start: 2006-03-13
Marketing end: 0000-00-00
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: 2023-12-31
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	67296-1034	67296-1034-3	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A077309-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2005-09-29
A077309-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2005-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077309-001	AB
A077309-002	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	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`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	A077309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077309-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077309-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077309-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077309-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077309-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077309-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077309-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077309-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077309-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077309-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077309-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077309-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077309-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077309-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077309-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077309-002	AB	1	`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
67296-1034-3	2024-01-30	C162847	48780-1	1030e365-67b6-111a-e063-dadaa90a10e2	4e2d06ed-7b2f-26d5-e054-00144ff88e88
67296-1034-5	2024-01-30	C162847	48780-1	1030e365-67b6-111a-e063-dadaa90a10e2	4e2d06ed-7b2f-26d5-e054-00144ff88e88
67296-1034-6	2024-01-30	C162847	48780-1	1030e365-67b6-111a-e063-dadaa90a10e2	4e2d06ed-7b2f-26d5-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1034-3	acyclovir	35 in 1 BOTTLE	TABLET	35	3
67296-1034-5	acyclovir	50 in 1 BOTTLE	TABLET	50	3
67296-1034-6	acyclovir	6 in 1 BOTTLE	TABLET	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1034	ACYCLOVIR TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 3 package rows	20220121_4e2d06ed-7b2f-26d5-e054-00144ff88e88.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	499c6a98-0614-4ded-8526-909942bae8a4	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	db35fce0-d7a3-4589-ba60-d78cdb1119cb	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Apotex Corp.	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	a7fd298b-3914-4316-8484-2d3ae188221a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	ada4004a-c10a-6190-e053-2a95a90a5e67	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b2ae0432-bd2a-1480-e053-2a95a90a6fc8	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	968800dc-9456-a45f-e053-2995a90aa15e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	bf1b4142-c5f3-4147-8224-bf6344566694	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Proficient Rx LP	4c5a75fa-73db-4f48-895f-de1635d33f49	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Asclemed USA, Inc.	e186fdc9-b60e-4280-8d60-36cae9f2838f	2020-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Proficient Rx LP	51052f0e-1a07-405a-a962-981ce9439e02	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309

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	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3
197313	acyclovir 800 MG Oral Tablet	SCD	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1034-3	67296103403	35 TABLET in 1 BOTTLE (67296-1034-3)	35 tablet	2006-03-13	0000-00-00	No	No	Current