Acyclovir

Product NDC: 82804-005
Requested package NDC: 82804-005-21
11-digit product format: 828040005
Labeler code: 82804
Product ID: 82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA210401
Marketing category: ANDA
Marketing start: 2023-06-20
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210401-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2018-03-07
A210401-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2018-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210401-001	AB
A210401-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210401-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2018-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210401-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2018-03-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210401-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210401-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210401-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210401-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210401-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210401-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210401-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210401-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210401-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210401-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210401-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210401-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210401-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210401-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210401-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210401-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210401-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210401-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210401-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210401-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210401-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210401-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210401-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210401-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210401-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197311	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
97ed8713-4b3e-48a9-92c0-0a98ecf0485c	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
82804-005-06	Acyclovir	6 in 1 BOTTLE	TABLET	6	2
82804-005-15	Acyclovir	15 in 1 BOTTLE	TABLET	15	2
82804-005-20	Acyclovir	20 in 1 BOTTLE	TABLET	20	2
82804-005-21	Acyclovir	21 in 1 BOTTLE	TABLET	21	2
82804-005-30	Acyclovir	30 in 1 BOTTLE	TABLET	30	2
82804-005-35	Acyclovir	35 in 1 BOTTLE	TABLET	35	2
82804-005-60	Acyclovir	60 in 1 BOTTLE	TABLET	60	2
82804-005-90	Acyclovir	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-005-21	EA - Each	82804-005	214b841f-38a7-4d5f-b068-e2958b11802d	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-005	ACYCLOVIR TABLET [PROFICIENT RX LP]	2	Current NDC, 8 package rows	20240112_97ed8713-4b3e-48a9-92c0-0a98ecf0485c.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	58dc1402-6098-9cb3-e063-6294a90a062b	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Redpharm Drug	53cbca4d-3ddc-b11e-e063-6394a90a04fa	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Westminster Pharmaceuticals, LLC	f352a641-988e-4878-8016-2b69cd6ee548	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	69e5455e-d0be-4c2b-b9ab-458b5480ed57	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	2e6a3667-af06-40de-80c0-8c4346e0671f	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	75334fc5-d236-401a-875c-f4f9c7749c1a	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	67e7b340-0635-2595-e053-2a91aa0ad266	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	YILING PHARMACEUTICAL, INC.	677edfd5-2d04-b932-e053-2a91aa0a26b0	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Redpharm Drug	37453bcd-e34e-5902-e063-6294a90a0245	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Chartwell RX, LLC	8cd22728-34b4-4e55-8339-580138fe46d8	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Proficient Rx LP	d0908b3c-f5dd-4113-9080-bb01abe13c9c	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8d171c3d-de39-4f82-bacb-3e8d71b16540	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	b96e44ca-aa54-4a64-89f4-fb5a5932ceae	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	c0c29e0f-b6e2-49df-88d1-95b7b625d356	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6ea3e3f6-132d-4b15-ac58-336de05201a7	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Proficient Rx LP	290af212-7332-4914-9ef0-65760478fb32	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401
Acyclovir	ACYCLOVIR	Proficient Rx LP	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210401 application number: ANDA210401 ndc (package): 82804-005-21 ndc (product): 82804-005 ndc11 (package): 82804000521

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	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2
197311	acyclovir 400 MG Oral Tablet	SCD	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2
197311	acycycloguanosine 400 MG Oral Tablet	SY	97ed8713-4b3e-48a9-92c0-0a98ecf0485c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-005-21	82804000521	21 TABLET in 1 BOTTLE (82804-005-21)	21 tablet	2024-01-09	No	No	Current