Acyclovir

Product NDC: 12634-520
11-digit product format: 126340520
Labeler code: 12634
Product ID: 12634-520_34f57b50-d012-2c77-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA074556
Marketing category: ANDA
Marketing start: 1997-04-23
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 · 27 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-520		I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-00	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-01	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-09	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-40	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-52	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-54	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-57	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-59	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-60	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-61	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-63	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-66	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-67	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-69	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-71	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-74	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-78	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-79	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-80	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-81	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-82	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-85	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-91	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-94	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-95	I	Inactivated by FDA	2026-10-15
excluded package	package	12634-520	12634-520-96	I	Inactivated by FDA	2026-10-15

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 10 · 567 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	12634-520-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-520-66	`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	12634-520-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-520-66	`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	12634-520-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-520-63	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-520-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-520-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-520-09	`2ef7874e63bc…`	`57b86245f4fa…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074556-001	ACYCLOVIR	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22
A074556-002	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22
A074556-003	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074556-002	AB
A074556-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074556-002	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074556-003	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074556-001	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1997-04-22	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074556-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074556-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074556-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074556-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074556-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074556-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074556-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074556-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074556-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074556-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074556-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074556-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074556-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074556-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074556-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074556-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074556-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074556-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074556-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074556-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074556-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074556-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074556-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074556-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074556-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074556-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074556-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074556-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074556-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074556-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074556-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074556-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074556-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074556-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074556-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074556-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074556-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074556-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074556-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074556-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
12634-520-00	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-01	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-09	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-40	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-52	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-54	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-57	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-59	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-60	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-61	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-63	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-66	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-67	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-69	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-71	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-74	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-78	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-79	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-80	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-81	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-82	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-85	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-91	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-94	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-95	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only
12634-520-96	ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-520-00	Acyclovir	10 in 1 BOTTLE	TABLET	10	2
12634-520-01	Acyclovir	100 in 1 BOTTLE	TABLET	100	2
12634-520-09	Acyclovir	35 in 1 BOTTLE	TABLET	35	2
12634-520-40	Acyclovir	40 in 1 BOTTLE	TABLET	40	2
12634-520-52	Acyclovir	12 in 1 BLISTER PACK	TABLET	12	2
12634-520-54	Acyclovir	14 in 1 BLISTER PACK	TABLET	14	2
12634-520-57	Acyclovir	20 in 1 BLISTER PACK	TABLET	20	2
12634-520-59	Acyclovir	30 in 1 BLISTER PACK	TABLET	30	2
12634-520-60	Acyclovir	60 in 1 BOTTLE	TABLET	60	2
12634-520-61	Acyclovir	10 in 1 BLISTER PACK	TABLET	10	2
12634-520-63	Acyclovir	3 in 1 BLISTER PACK	TABLET	3	2
12634-520-66	Acyclovir	6 in 1 BLISTER PACK	TABLET	6	2
12634-520-67	Acyclovir	7 in 1 BLISTER PACK	TABLET	7	2
12634-520-69	Acyclovir	9 in 1 BLISTER PACK	TABLET	9	2
12634-520-71	Acyclovir	30 in 1 BOTTLE	TABLET	30	2
12634-520-74	Acyclovir	24 in 1 BOTTLE	TABLET	24	2
12634-520-78	Acyclovir	28 in 1 BOTTLE	TABLET	28	2
12634-520-79	Acyclovir	25 in 1 BOTTLE	TABLET	25	2
12634-520-80	Acyclovir	20 in 1 BOTTLE	TABLET	20	2
12634-520-81	Acyclovir	21 in 1 BOTTLE	TABLET	21	2
12634-520-82	Acyclovir	12 in 1 BOTTLE	TABLET	12	2
12634-520-85	Acyclovir	15 in 1 BOTTLE	TABLET	15	2
12634-520-91	Acyclovir	1 in 1 BLISTER PACK	TABLET	1	2
12634-520-94	Acyclovir	4 in 1 BOTTLE	TABLET	4	2
12634-520-95	Acyclovir	5 in 1 BOTTLE	TABLET	5	2
12634-520-96	Acyclovir	6 in 1 BOTTLE	TABLET	6	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-520	ACYCLOVIR TABLET [APOTHECA INC.]	2	Legacy NDC, 26 package rows	20160611_34f57b50-d013-2c77-e054-00144ff88e88.zip

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	34f57b50-d013-2c77-e054-00144ff88e88	2
197311	acyclovir 400 MG Oral Tablet	SCD	34f57b50-d013-2c77-e054-00144ff88e88	2
197311	acycycloguanosine 400 MG Oral Tablet	SY	34f57b50-d013-2c77-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-520-00	12634052000	10 in 1 BOTTLE	Historical
12634-520-01	12634052001	100 in 1 BOTTLE	Historical
12634-520-09	12634052009	35 in 1 BOTTLE	Historical
12634-520-40	12634052040	40 in 1 BOTTLE	Historical
12634-520-52	12634052052	12 in 1 BLISTER PACK	Historical
12634-520-54	12634052054	14 in 1 BLISTER PACK	Historical
12634-520-57	12634052057	20 in 1 BLISTER PACK	Historical
12634-520-59	12634052059	30 in 1 BLISTER PACK	Historical
12634-520-60	12634052060	60 in 1 BOTTLE	Historical
12634-520-61	12634052061	10 in 1 BLISTER PACK	Historical
12634-520-63	12634052063	3 in 1 BLISTER PACK	Historical
12634-520-66	12634052066	6 in 1 BLISTER PACK	Historical
12634-520-67	12634052067	7 in 1 BLISTER PACK	Historical
12634-520-69	12634052069	9 in 1 BLISTER PACK	Historical
12634-520-71	12634052071	30 in 1 BOTTLE	Historical
12634-520-74	12634052074	24 in 1 BOTTLE	Historical
12634-520-78	12634052078	28 in 1 BOTTLE	Historical
12634-520-79	12634052079	25 in 1 BOTTLE	Historical
12634-520-80	12634052080	20 in 1 BOTTLE	Historical
12634-520-81	12634052081	21 in 1 BOTTLE	Historical
12634-520-82	12634052082	12 in 1 BOTTLE	Historical
12634-520-85	12634052085	15 in 1 BOTTLE	Historical
12634-520-91	12634052091	1 in 1 BLISTER PACK	Historical
12634-520-94	12634052094	4 in 1 BOTTLE	Historical
12634-520-95	12634052095	5 in 1 BOTTLE	Historical
12634-520-96	12634052096	6 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP Rx only	Apotheca Inc.	2016-06-10	HUMAN PRESCRIPTION DRUG LABEL	2