Acyclovix

Product NDC: 72275-733
11-digit product format: 722750733
Labeler code: 72275
Product ID: 72275-733_b001f962-f918-a0c3-e053-2995a90a179f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: KIT
Route: ORAL; TOPICAL
Labeler: Primary Pharmaceuticals, Inc.
Application: ANDA206261
Marketing category: ANDA
Marketing start: 2020-09-20
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72275-733		D	Discontinued by firm		2026-08-03
excluded package	package	72275-733	72275-733-77	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72275-733-77	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72275-733-77	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72275-733-77	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72275-733-77	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72275-733-77	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72275-733-77	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72275-733-77	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72275-733-77	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72275-733-77	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72275-733-77	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72275-733-77	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72275-733-77	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72275-733-77	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72275-733-77	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72275-733-77	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A206261-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2017-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206261-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`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	A206261-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72275-733-77	2025-02-27	C162847	48780-1	f386c64a-11d7-0266-e053-dadaa90a7c1a	Acyclovix
72275-733-77	2023-01-30	C162847	48780-1	f386c64a-11d7-0266-e053-dadaa90a7c1a	Acyclovix

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72275-733-77	EA - Each	72275-733	819e48ab-634d-45bc-b225-22667ac0c815	1	2021-02-05

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	Golden State Medical Supply, Inc.	0d99ba77-c3c5-1fd0-e063-6294a90a6f2a	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	af9d41f5-4658-4487-8811-32a1f8af9384	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	01ae85df-d1a0-44f7-b4c0-0ac74d2216d4	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	37499620-6a17-40f1-b0db-dd79320ea21d	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b455053f-3deb-bd76-e053-2a95a90a9869	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Proficient Rx LP	e8056ec6-d2dc-48af-8550-82726af1c5c5	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261

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
72275-733-77	72275073377	1 KIT in 1 CARTON (72275-733-77) * 7.1 g in 1 TUBE * 100 CAPSULE in 1 BOTTLE	1 kit	2020-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovix	Primary Pharmaceuticals, Inc. \| Rainbow Gold Products, Inc. \| Carlsbad Technology, Inc.	2020-09-21	HUMAN PRESCRIPTION DRUG LABEL	1