acyclovir

Product NDC: 53217-188
11-digit product format: 532170188
Labeler code: 53217
Product ID: 53217-188_6d774336-edd3-4d24-b05c-6a54f44016d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA204314
Marketing category: ANDA
Marketing start: 2014-09-10
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: 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-188		I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-15	I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-21	I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-25	I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-30	I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-50	I	Inactivated by FDA	2026-08-10
excluded package	package	53217-188	53217-188-60	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 · 147 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	53217-188-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-188-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-188-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-188-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-188-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-188-60	`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	53217-188-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-188-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-188-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-188-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-188-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-188-60	`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	53217-188-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-188-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-188-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-188-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-188-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-188-60	`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	53217-188-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-188-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-188-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-188-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-188-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-188-60	`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	53217-188-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-188-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-188-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-188-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-188-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-188-60	`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	53217-188-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-188-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-188-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-188-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-188-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-188-60	`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	53217-188-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-188-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-188-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-188-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-188-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-188-60	`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	53217-188-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-188-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-188-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-188-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-188-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-188-60	`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	53217-188-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-188-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-188-50	`0efc9e666f02…`	`f202fb6c5f17…`

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
A204314-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2014-08-19
A204314-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204314-001	AB
A204314-002	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	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204314-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2014-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204314-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2014-08-19	`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	A204314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204314-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204314-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204314-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204314-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204314-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204314-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204314-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204314-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204314-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204314-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204314-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204314-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204314-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204314-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204314-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204314-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204314-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204314-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204314-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204314-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204314-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204314-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204314-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204314-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204314-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204314-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204314-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204314-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204314-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204314-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204314-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204314-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204314-002	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
53217-188-15	Acyclovir Tablets, USP Rx only
53217-188-21	Acyclovir Tablets, USP Rx only
53217-188-25	Acyclovir Tablets, USP Rx only
53217-188-30	Acyclovir Tablets, USP Rx only
53217-188-50	Acyclovir Tablets, USP Rx only
53217-188-60	Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-188-15	acyclovir	15 in 1 BOTTLE	TABLET	15	1
53217-188-21	acyclovir	21 in 1 BOTTLE	TABLET	21	1
53217-188-25	acyclovir	25 in 1 BOTTLE	TABLET	25	1
53217-188-30	acyclovir	30 in 1 BOTTLE	TABLET	30	1
53217-188-50	acyclovir	50 in 1 BOTTLE	TABLET	50	1
53217-188-60	acyclovir	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-188-15	EA - Each	53217-188	50f28cf7-b9f0-48e3-9bdb-81c5d918ffa0	1	2017-03-06
53217-188-21	EA - Each	53217-188	15e56226-436a-47ac-be2c-b3aed43afe89	1	2017-03-06
53217-188-25	EA - Each	53217-188	a5e81261-7147-4161-bc42-af716e85f093	1	2017-03-06
53217-188-30	EA - Each	53217-188	f550b53b-764c-49a7-a34b-a9303be030b7	1	2017-03-06
53217-188-50	EA - Each	53217-188	8ce9f1d9-1f15-4fa6-bbf4-25b5799e3740	1	2017-03-06
53217-188-60	EA - Each	53217-188	b748ed1b-4b27-409a-91bb-5f932b7d5ec8	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-188	ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 6 package rows	20170225_3399cc2e-8596-450d-91df-434dac0aab85.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	Northwind Health Company, LLC	50c58161-3944-7367-e063-6394a90a6286	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	960e4ede-692e-4db2-a96e-dc6f4a6190ee	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	8fdabab2-bc93-48ab-9c13-d22ec90fdcfc	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	8d9fea43-6c04-40d7-8aac-398c2de2a558	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	Zydus Pharmaceuticals (USA) Inc.	edb0cd28-ee57-4b60-be94-62c797fbf5e6	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	Coupler LLC	2cdbea8d-29df-0045-e063-6294a90a9506	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals, Inc.	40e5cc54-ed74-3369-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	A-S Medication Solutions	f3e6b1ad-810b-4f53-b92a-b28fc2111f3f	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	A-S Medication Solutions	c40a57b9-4cf1-4a69-abf3-eb99a7fcda00	2023-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314
acyclovir	ACYCLOVIR	Proficient Rx LP	3da54b2d-a206-4ff5-8cc2-90762c4fd70d	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204314 application number: ANDA204314

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	3399cc2e-8596-450d-91df-434dac0aab85	1
197311	acyclovir 400 MG Oral Tablet	SCD	3399cc2e-8596-450d-91df-434dac0aab85	1
197311	acycycloguanosine 400 MG Oral Tablet	SY	3399cc2e-8596-450d-91df-434dac0aab85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-188-15	53217018815	15 in 1 BOTTLE	Historical
53217-188-21	53217018821	21 in 1 BOTTLE	Historical
53217-188-25	53217018825	25 in 1 BOTTLE	Historical
53217-188-30	53217018830	30 in 1 BOTTLE	Historical
53217-188-50	53217018850	50 in 1 BOTTLE	Historical
53217-188-60	53217018860	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets, USP Rx only	Aidarex Pharmaceuticals LLC	2017-02-24	HUMAN PRESCRIPTION DRUG LABEL	1