acyclovir

Product NDC: 68382-668
11-digit product format: 683820668
Labeler code: 68382
Product ID: 68382-668_beded6e9-8043-4b8f-a048-4ebb0a6be58e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA204313
Marketing category: ANDA
Marketing start: 2016-05-03
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: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-668		I	Inactivated by FDA	2026-08-10
excluded package	package	68382-668	68382-668-01	I	Inactivated by FDA	2026-08-10
excluded package	package	68382-668	68382-668-05	I	Inactivated by FDA	2026-08-10
excluded package	package	68382-668	68382-668-06	I	Inactivated by FDA	2026-08-10
excluded package	package	68382-668	68382-668-10	I	Inactivated by FDA	2026-08-10
excluded package	package	68382-668	68382-668-16	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 3 · 126 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	68382-668-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-668-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-668-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-668-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-668-16	`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	68382-668-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-668-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-668-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-668-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-668-16	`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	68382-668-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-668-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-668-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-668-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-668-16	`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	68382-668-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-668-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-668-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-668-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-668-16	`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	68382-668-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-668-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-668-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-668-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-668-16	`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	68382-668-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-668-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-668-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-668-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-668-16	`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	68382-668-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-668-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-668-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-668-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-668-16	`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	68382-668-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-668-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-668-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-668-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-668-16	`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	68382-668-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-668-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-668-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-668-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-668-16	`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	68382-668-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-668-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-668-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-668-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-668-16	`ad56d346431e…`	`cc804d4bbf1e…`

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
A204313-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204313-001	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	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`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	A204313-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	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
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, Related label table
NDC	Related label
68382-668-01	Acyclovir Capsules, USP Rx only
68382-668-05	Acyclovir Capsules, USP Rx only
68382-668-06	Acyclovir Capsules, USP Rx only
68382-668-10	Acyclovir Capsules, USP Rx only
68382-668-16	Acyclovir Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-668-01	acyclovir	100 in 1 BOTTLE	CAPSULE	100	2
68382-668-05	acyclovir	500 in 1 BOTTLE	CAPSULE	500	2
68382-668-06	acyclovir	30 in 1 BOTTLE	CAPSULE	30	2
68382-668-10	acyclovir	1000 in 1 BOTTLE	CAPSULE	1000	2
68382-668-16	acyclovir	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-668	ACYCLOVIR CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]	2	Legacy NDC, 5 package rows	20160512_4c744bf4-7086-40f0-9091-e4096d4e9d41.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	86c43bdf-c5bf-47cd-8dfd-811263825878	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Proficient Rx LP	d4729677-164b-41b8-bbc4-4e47346b0f72	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	0990b625-5dfe-4810-b5b4-ac5948599e79	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	A-S Medication Solutions	a0ed999f-7366-42c3-a6f5-3c239215a99c	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Northwind Health Company, LLC	ff9776b3-a248-e1ea-e053-6294a90aeb7b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	e580b7e9-9060-43f5-9b58-33998078d7e4	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	395cd839-21e1-43e2-a8ce-078f07bc7668	2025-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4	2025-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313

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	4c744bf4-7086-40f0-9091-e4096d4e9d41	2
197310	acyclovir 200 MG Oral Capsule	SCD	4c744bf4-7086-40f0-9091-e4096d4e9d41	2
197310	acycycloguanosine 200 MG Oral Capsule	SY	4c744bf4-7086-40f0-9091-e4096d4e9d41	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68382-668-01	68382066801	100 in 1 BOTTLE	Historical
68382-668-05	68382066805	500 in 1 BOTTLE	Historical
68382-668-06	68382066806	30 in 1 BOTTLE	Historical
68382-668-10	68382066810	1000 in 1 BOTTLE	Historical
68382-668-16	68382066816	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Capsules, USP Rx only	Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2016-05-12	HUMAN PRESCRIPTION DRUG LABEL	2