ACYCLOVIR

Product NDC: 43063-826
11-digit product format: 430630826
Labeler code: 43063
Product ID: 43063-826_de2184a8-33c8-c4cd-e053-2995a90ad314
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA075677
Marketing category: ANDA
Marketing start: 2006-03-20
Marketing end: 0000-00-00
Substance: ACYCLOVIR
Active strength: 200 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-826		D	Discontinued by firm	2026-08-03
excluded package	package	43063-826	43063-826-05	D	Discontinued by firm	2026-08-03
excluded package	package	43063-826	43063-826-50	D	Discontinued by firm	2026-08-03

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	43063-826		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-826	43063-826-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-826	43063-826-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075677-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075677-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075677-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075677-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075677-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075677-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075677-001	AB	1	`cb3db0bc1861…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-826-05	EA - Each	43063-826	8631d013-7701-4089-8577-2ed8dfb65e03	1	2018-05-09
43063-826-50	EA - Each	43063-826	1756e951-3f36-41c8-a78b-4f3f2fbf4b81	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-826	ACYCLOVIR CAPSULE [PD-RX PHARMACEUTICALS, INC.]	13	Legacy NDC	20240703_38277d3a-1b38-4bc4-9dd5-6f0f7a237b85.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	2b600b5d-ce91-461f-b9d1-75b969daf8e9	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Major Pharmaceuticals	864d96b9-e2de-45a8-850b-6f7b72ceefe1	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Cardinal Health 107, LLC	7484b631-18f9-440d-bb11-a44932fec6e7	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	e5356160-cb35-4ff6-91d5-2ade594e0279	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Apotex Corp.	41bea43a-f58c-2c6f-4d31-406ceb456077	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	2020-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677

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
43063-826-05	43063082605	5 CAPSULE in 1 BOTTLE, PLASTIC (43063-826-05)	5 capsule	2018-04-03	0000-00-00	No	No	Current
43063-826-50	43063082650	50 CAPSULE in 1 BOTTLE, PLASTIC (43063-826-50)	50 capsule	2018-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES USP 200 mg	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	14