Acyclovir

Product NDC: 76483-047
Requested package NDC: 76483-047-00
11-digit product format: 764830047
Labeler code: 76483
Product ID: 76483-047_2b705cc7-7286-4acb-a3e7-95c65fc90bc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: SQUARE PHARMACEUTICALS LIMITED
Application: ANDA209366
Marketing category: ANDA
Marketing start: 2020-01-31
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

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 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76483-047	76483-047-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76483-047	76483-047-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76483-047	76483-047-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

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
A209366-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2019-10-07
A209366-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209366-001	AB
A209366-002	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 2 · 78 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	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209366-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2019-10-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209366-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2019-10-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A209366-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209366-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209366-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209366-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209366-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209366-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209366-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209366-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209366-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209366-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209366-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209366-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209366-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209366-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209366-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209366-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209366-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209366-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209366-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209366-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209366-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209366-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209366-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209366-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209366-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209366-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209366-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209366-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209366-002	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
b24201ea-aeae-4de1-b01b-eee89068e786	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76483-047-00	2023-07-03	Acyclovir Tablets USP
76483-047-04	2023-07-03	Acyclovir Tablets USP
76483-047-05	2023-07-03	Acyclovir Tablets USP
76483-047-00	2022-01-28	Acyclovir Tablets USP
76483-047-04	2022-01-28	Acyclovir Tablets USP
76483-047-05	2022-01-28	Acyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76483-047-00	Acyclovir	30 in 1 BOTTLE	TABLET	30	5
76483-047-04	Acyclovir	100 in 1 BOTTLE	TABLET	100	5
76483-047-05	Acyclovir	500 in 1 BOTTLE	TABLET	500	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76483-047	ACYCLOVIR TABLET [SQUARE PHARMACEUTICALS LIMITED]	5	Current NDC, Legacy NDC, 3 package rows	20230706_b24201ea-aeae-4de1-b01b-eee89068e786.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	37a51d9c-1f39-4065-8c7d-6528ac6de91c	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc.	b1033fda-8242-4006-b1cd-23474d70671f	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	a1086845-ba08-4fb2-81dc-aea9c68bf2c3	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Direct_Rx	387d33ed-45e5-42d6-e063-6294a90afbb7	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	067109d0-2539-42b6-9e95-102b58ca54dc	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	713960c2-8278-4778-b781-08ec89a9cfce	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	116f4f0d-66c5-49dd-e063-6394a90ab2b5	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	e5e99a6b-79a6-7fdb-e053-2a95a90a8563	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e73ae5c8-7a77-4330-817d-482d1de4e994	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	Bionpharma Inc.	6f1db9f0-9b41-4fb7-8798-44fdc2c128df	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366
Acyclovir	ACYCLOVIR	SQUARE PHARMACEUTICALS LIMITED	b24201ea-aeae-4de1-b01b-eee89068e786	2023-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366 ndc (package): 76483-047-00 ndc (product): 76483-047 ndc11 (package): 76483004700
Acyclovir	ACYCLOVIR	A-S Medication Solutions	34a38cdf-04e8-4006-a9f5-4a0831117d61	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209366 application number: ANDA209366

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	b24201ea-aeae-4de1-b01b-eee89068e786	5
197313	acyclovir 800 MG Oral Tablet	PSN	b24201ea-aeae-4de1-b01b-eee89068e786	5
197311	acyclovir 400 MG Oral Tablet	SCD	b24201ea-aeae-4de1-b01b-eee89068e786	5
197313	acyclovir 800 MG Oral Tablet	SCD	b24201ea-aeae-4de1-b01b-eee89068e786	5
197311	acycycloguanosine 400 MG Oral Tablet	SY	b24201ea-aeae-4de1-b01b-eee89068e786	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	b24201ea-aeae-4de1-b01b-eee89068e786	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76483-047-00	76483004700	30 TABLET in 1 BOTTLE (76483-047-00)	30 tablet	2020-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets USP	SQUARE PHARMACEUTICALS LIMITED \| SQUARE PHARMACEUTICALS LIMITED, Dhaka unit	2023-07-02	HUMAN PRESCRIPTION DRUG LABEL	5