ACYCLOVIR

Product NDC: 60687-867
11-digit product format: 606870867
Labeler code: 60687
Product ID: 60687-867_4a03039d-ae31-10ea-e063-6294a90a1e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA074891
Marketing category: ANDA
Marketing start: 2025-06-06
Substance: ACYCLOVIR
Active strength: 800 mg/1
Pharmacologic classes: DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A074891-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		1997-10-31
A074891-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		1997-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074891-001	AB
A074891-002	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	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074891-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1997-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074891-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1997-10-31	`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	A074891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074891-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074891-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074891-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074891-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074891-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074891-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074891-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074891-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074891-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074891-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074891-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074891-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074891-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074891-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074891-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074891-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074891-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074891-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074891-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074891-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074891-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074891-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074891-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074891-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074891-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074891-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074891-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074891-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074891-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074891-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACYCLOVIR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4HES1O11F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197311	Internal RxNorm lookup
197313	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05f42300-2a06-45f1-a9b9-6e5c84ae58ec	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-867-01	ACYCLOVIR	100 in 1 CARTON	TABLET	100		5
60687-867-11	ACYCLOVIR	1 in 1 BLISTER PACK	TABLET	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-867-01	EA - Each	60687-867	5578f816-ecfc-4664-9ef6-8e7ba6eeeec9	1	2025-03-04
60687-867-11	EA - Each	60687-867	5a7bb87c-017c-4b7d-b5cb-42f0c44e5dad	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-867	ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]	2	Current NDC, 2 package rows	20250507_05f42300-2a06-45f1-a9b9-6e5c84ae58ec.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACYCLOVIR	ACYCLOVIR	American Health Packaging	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891 ndc (product): 60687-867
ACYCLOVIR	ACYCLOVIR	REMEDYREPACK INC.	c1744e01-0e40-4851-8ffc-c3bf29dd7c2b	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891
ACYCLOVIR	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b1b999a9-11cc-d6e5-e053-2995a90a5478	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	331fe0bd-6bb2-4337-8faa-d0c82ff54dc7	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	c0e41bf9-e141-404e-9952-aeeb705958b4	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891
ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0de2f5c7-9e75-4bdf-9c28-e026cc6694b4	2023-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891
ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	32aa3f42-23a1-4867-8228-e6e76cf9f135	2022-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074891 application number: ANDA074891

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	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5
197313	acyclovir 800 MG Oral Tablet	PSN	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5
197311	acyclovir 400 MG Oral Tablet	SCD	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5
197313	acyclovir 800 MG Oral Tablet	SCD	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5
197311	acycycloguanosine 400 MG Oral Tablet	SY	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	05f42300-2a06-45f1-a9b9-6e5c84ae58ec	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-867-01	60687086701	100 BLISTER PACK in 1 CARTON (60687-867-01) / 1 TABLET in 1 BLISTER PACK (60687-867-11)	100 blister pack	2025-06-06	No	No	Current
60687-867-11	60687086711	1 in 1 BLISTER PACK					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets, USP 8485601/1225 Rx only	American Health Packaging	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	5