acyclovir

Product NDC: 60760-606
11-digit product format: 607600606
Labeler code: 60760
Product ID: 60760-606_cdb55e30-057a-5d3b-e053-2a95a90ae79c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA204313
Marketing category: ANDA
Marketing start: 2021-08-30
Marketing end: 0000-00-00
Substance: ACYCLOVIR
Active strength: 200 mg/1
Pharmacologic classes: DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60760-606		D	Discontinued by firm		2026-08-10
excluded package	package	60760-606	60760-606-60	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204313-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204313-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204313-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-606-60	EA - Each	60760-606	e675d019-7f31-4bbb-a21b-37f4bff326a8	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-606	ACYCLOVIR CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]	1	Legacy NDC	20211012_cdb55e30-0579-5d3b-e053-2a95a90ae79c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-606-60	60760060660	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-606-60)	60 capsule	2021-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Capsules, USP Rx only	St. Mary's Medical Park Pharmacy	2021-10-06	HUMAN PRESCRIPTION DRUG LABEL	1