ACYCLOVIR

Product NDC: 61919-654
11-digit product format: 619190654
Labeler code: 61919
Product ID: 61919-654_879d96b3-0ad3-4927-9a4d-bc0908d2d387
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: TABLET
Route: ORAL
Labeler: DirectRX
Application: ANDA203834
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: ACYCLOVIR
Active strength: 400 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-654		I	Inactivated by FDA	2026-08-10
excluded product	product	61919-654		I	Inactivated by FDA	2026-08-10
excluded package	package	61919-654	61919-654-14	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-654	61919-654-30	I	Inactivated by FDA	2026-08-10
excluded package	package	61919-654	61919-654-40	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 2 · 84 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-654-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-654-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-654-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-654-40	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-654-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-654-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-654-40	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-654-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-654-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-654-40	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-654-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-654-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-654-40	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-654-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-654-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-654-40	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-654-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-654-30	I	Inactivated by FDA	`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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-654-14	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-654-40	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-654-30	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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-654-14	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-654-40	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-654-30	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 product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-654-14	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-654-40	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-654-30	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	61919-654-40	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-654-30	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	61919-654-40	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-654-30	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	61919-654-40	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-654-30	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	61919-654-40	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-654-30	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	61919-654-40	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-654-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`

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
A203834-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29
A203834-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203834-001	AB
A203834-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`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	A203834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203834-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203834-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203834-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203834-002	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
61919-654-14	2025-01-30	C162847	48780-1	2cef2736-9de8-d83d-e063-dadaa90ab31f	Acyclovir
61919-654-30	2020-01-31	C162847	48780-1	9d75b9d1-2982-f424-e053-dadaa90a57ce	ACYCLOVIR
61919-654-40	2020-01-31	C162847	48780-1	9d75b9d1-2982-f424-e053-dadaa90a57ce	ACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-654-30	ACYCLOVIR	30 in 1 BOTTLE	TABLET	30	2
61919-654-40	ACYCLOVIR	40 in 1 BOTTLE	TABLET	40	2
61919-654-14	Acyclovir	14 in 1 BOTTLE	TABLET	14	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-654-14	EA - Each	61919-654	4ebc474a-45f6-48c9-931b-d0c78bfd2a34	1	2023-10-16
61919-654-30	EA - Each	61919-654	d320fa9f-f9e6-489c-8676-3ee11972b5f8	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [DIRECTRX]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [DIRECTRX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [DIRECTRX]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [DIRECTRX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACYCLOVIR TABLET [DIRECTRX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [DIRECTRX]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACYCLOVIR TABLET [DIRECTRX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [DIRECTRX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-654	ACYCLOVIR TABLET [DIRECTRX]	2	Legacy NDC, 2 package rows	20151105_96fcc438-fc47-456c-bf31-6df278b12244.zip
61919-654	ACYCLOVIR TABLET [DIRECT_RX]	1	Legacy NDC, 1 package rows	20230912_0514f788-1b06-9239-e063-6294a90a8ac2.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	6d0e492e-5359-49e8-812d-8c8e2e5d42f8	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	736679be-469e-4bdb-8e15-b10751c3dd60	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	38547daa-7d2f-4a7b-84d3-6e164984f958	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Major Pharmaceuticals	46150f19-ce5d-42a0-80a7-f96fda2b9879	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals, Inc.	b6d69697-12bb-4548-a6c3-2463cbf54f8f	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Camber Pharmaceuticals, Inc.	0910335b-6796-459f-b97e-d7ef5439a060	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	5dcfd21c-43f0-469c-be70-a4e74e6ccf88	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	f6f56143-ea74-af87-e053-6394a90ae346	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Advanced Rx Pharmacy of Tennessee, LLC	f4c5779d-e4bf-4f2b-e053-2995a90a9187	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	638803d2-a172-486d-e053-2991aa0ab074	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals, Inc.	5176c7f9-9076-4797-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	83e82707-85b6-2fea-e053-2991aa0a99ef	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	A-S Medication Solutions	e4f91376-9e18-41a4-aa5e-adcea0c625d9	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	8fb01f23-e2bd-6850-e053-2995a90a7cc5	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834

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	96fcc438-fc47-456c-bf31-6df278b12244	2
197311	acyclovir 400 MG Oral Tablet	SCD	96fcc438-fc47-456c-bf31-6df278b12244	2
197311	acycycloguanosine 400 MG Oral Tablet	SY	96fcc438-fc47-456c-bf31-6df278b12244	2
197311	acyclovir 400 MG Oral Tablet	PSN	0514f788-1b06-9239-e063-6294a90a8ac2	1
197311	acyclovir 400 MG Oral Tablet	SCD	0514f788-1b06-9239-e063-6294a90a8ac2	1
197311	acycycloguanosine 400 MG Oral Tablet	SY	0514f788-1b06-9239-e063-6294a90a8ac2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-654-14	61919065414	14 in 1 BOTTLE	Historical
61919-654-30	61919065430	30 in 1 BOTTLE	Historical
61919-654-40	61919065440	40 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir	Direct_Rx	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
ACYCLOVIR	DirectRX	2015-11-04	HUMAN PRESCRIPTION DRUG LABEL	2