acyclovir

Product NDC: 65841-802
11-digit product format: 658410802
Labeler code: 65841
Product ID: 65841-802_b401b7c4-9c22-470f-981e-da74bef39dc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA204314
Marketing category: ANDA
Marketing start: 2014-09-10
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: 2026-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: acyclovir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	400 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
8d9fea43-6c04-40d7-8aac-398c2de2a558	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	SPL version
65841-802-01	acyclovir	100 in 1 BOTTLE	TABLET	100	5
65841-802-05	acyclovir	500 in 1 BOTTLE	TABLET	500	5
65841-802-06	acyclovir	30 in 1 BOTTLE	TABLET	30	5
65841-802-10	acyclovir	1000 in 1 BOTTLE	TABLET	1000	5
65841-802-16	acyclovir	90 in 1 BOTTLE	TABLET	90	5
65841-802-30	acyclovir	10 in 1 CARTON	TABLET	10	5
65841-802-30	acyclovir	10 in 1 BLISTER PACK	TABLET	10	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR TABLET [CADILA HEALTHCARE LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-802	ACYCLOVIR TABLET [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 7 package rows	20231025_8d9fea43-6c04-40d7-8aac-398c2de2a558.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 ndc (product): 65841-802
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	8d9fea43-6c04-40d7-8aac-398c2de2a558	5
197313	acyclovir 800 MG Oral Tablet	PSN	8d9fea43-6c04-40d7-8aac-398c2de2a558	5
197311	acyclovir 400 MG Oral Tablet	SCD	8d9fea43-6c04-40d7-8aac-398c2de2a558	5
197313	acyclovir 800 MG Oral Tablet	SCD	8d9fea43-6c04-40d7-8aac-398c2de2a558	5
197311	acycycloguanosine 400 MG Oral Tablet	SY	8d9fea43-6c04-40d7-8aac-398c2de2a558	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	8d9fea43-6c04-40d7-8aac-398c2de2a558	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-802-01	65841080201	100 TABLET in 1 BOTTLE (65841-802-01)	100 tablet	2014-09-10	0000-00-00	No	No	Current
65841-802-05	65841080205	500 TABLET in 1 BOTTLE (65841-802-05)	500 tablet	2014-09-10	0000-00-00	No	No	Current
65841-802-06	65841080206	30 TABLET in 1 BOTTLE (65841-802-06)	30 tablet	2014-09-10	0000-00-00	No	No	Current
65841-802-10	65841080210	1000 TABLET in 1 BOTTLE (65841-802-10)	1000 tablet	2014-09-10	0000-00-00	No	No	Current
65841-802-16	65841080216	90 TABLET in 1 BOTTLE (65841-802-16)	90 tablet	2014-09-10	0000-00-00	No	No	Current
65841-802-30	65841080230	10 BLISTER PACK in 1 CARTON (65841-802-30) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2014-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets, USP Rx only	Zydus Lifesciences Limited	2025-11-27	HUMAN PRESCRIPTION DRUG LABEL	5