Acyclovir

Product NDC: 42254-198
11-digit product format: 422540198
Labeler code: 42254
Product ID: 42254-198_ec3d8135-2892-4186-ac31-c7deadd0b975
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075382
Marketing category: ANDA
Marketing start: 2009-10-22
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: E
Listing certified through: 2017-12-31
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	42254-198		I	Inactivated by FDA	2026-08-10
excluded package	package	42254-198	42254-198-21	I	Inactivated by FDA	2026-08-10
excluded package	package	42254-198	42254-198-25	I	Inactivated by FDA	2026-08-10
excluded package	package	42254-198	42254-198-30	I	Inactivated by FDA	2026-08-10
excluded package	package	42254-198	42254-198-35	I	Inactivated by FDA	2026-08-10
excluded package	package	42254-198	42254-198-50	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 · 132 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	42254-198-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-198-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-198-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-198-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-198-35	`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	42254-198-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-198-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-198-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-198-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-198-35	`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	42254-198-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-198-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-198-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-198-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-198-35	`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	42254-198-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-198-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-198-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-198-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-198-35	`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	42254-198-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-198-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-198-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-198-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-198-35	`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	42254-198-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-198-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-198-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-198-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-198-35	`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	42254-198-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-198-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-198-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-198-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-198-35	`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	42254-198-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-198-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-198-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-198-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-198-35	`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	42254-198-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-198-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-198-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-198-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-198-35	`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	42254-198-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-198-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-198-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-198-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-198-35	`ad56d346431e…`	`cc804d4bbf1e…`

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…`

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
42254-198-21	Acyclovir
42254-198-25	Acyclovir
42254-198-30	Acyclovir
42254-198-35	Acyclovir
42254-198-50	Acyclovir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42254-198-21	Acyclovir	21 in 1 BOTTLE	TABLET	21	3
42254-198-25	Acyclovir	25 in 1 BOTTLE	TABLET	25	3
42254-198-30	Acyclovir	30 in 1 BOTTLE	TABLET	30	3
42254-198-35	Acyclovir	35 in 1 BOTTLE	TABLET	35	3
42254-198-50	Acyclovir	50 in 1 BOTTLE	TABLET	50	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-198-21	EA - Each	42254-198	18cd57e5-6fbc-4ffa-ab11-e40ee0580650	1	2013-02-19
42254-198-25	EA - Each	42254-198	fa295944-bb21-49bf-956d-9ad5e0bd87f0	1	2013-02-19
42254-198-30	EA - Each	42254-198	be795e37-9fc7-443a-8cae-483ab03a1da6	1	2013-04-01
42254-198-35	EA - Each	42254-198	31cdcf90-6771-4d24-9b1d-e4cd5361acd7	1	2012-07-24
42254-198-50	EA - Each	42254-198	6cbdfcea-11f9-422d-81a8-d79a36027f42	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acyclovir	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
acyclovir	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-198	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3	Legacy NDC, 5 package rows	20130329_bf1e7864-07c5-4c2c-a075-fad00612ee2a.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197311	acyclovir 400 MG Oral Tablet	PSN	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	PSN	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197311	acyclovir 400 MG Oral Tablet	SCD	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	SCD	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197311	acycycloguanosine 400 MG Oral Tablet	SY	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-198-21	42254019821	21 in 1 BOTTLE	Historical
42254-198-25	42254019825	25 in 1 BOTTLE	Historical
42254-198-30	42254019830	30 in 1 BOTTLE	Historical
42254-198-35	42254019835	35 in 1 BOTTLE	Historical
42254-198-50	42254019850	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-04-04	HUMAN PRESCRIPTION DRUG LABEL	3