ACYCLOVIR

Product NDC: 71335-1757
Requested package NDC: 71335-1757-2
11-digit product format: 713351757
Labeler code: 71335
Product ID: 71335-1757_45462e20-c9a7-48c1-a1b4-13a1be79a3e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074891
Marketing category: ANDA
Marketing start: 2013-08-08
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 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1757	71335-1757-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1757	71335-1757-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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: 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 · 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
c0e41bf9-e141-404e-9952-aeeb705958b4	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
71335-1757-1	2024-05-17	Acyclovir Tablets, USP Rx only
71335-1757-2	2024-05-17	Acyclovir Tablets, USP Rx only
71335-1757-1	2024-01-30	Acyclovir Tablets, USP Rx only
71335-1757-2	2024-01-30	Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-1757-1	ACYCLOVIR	35 in 1 BOTTLE	TABLET	35		102
71335-1757-2	ACYCLOVIR	90 in 1 BOTTLE	TABLET	90		102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1757	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 2 package rows	20240518_c0e41bf9-e141-404e-9952-aeeb705958b4.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
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 ndc (package): 71335-1757-2 ndc (product): 71335-1757 ndc11 (package): 71335175702
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	c0e41bf9-e141-404e-9952-aeeb705958b4	102
197311	acyclovir 400 MG Oral Tablet	SCD	c0e41bf9-e141-404e-9952-aeeb705958b4	102
197311	acycycloguanosine 400 MG Oral Tablet	SY	c0e41bf9-e141-404e-9952-aeeb705958b4	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1757-2	71335175702	90 TABLET in 1 BOTTLE (71335-1757-2)	90 tablet	2021-01-04	0000-00-00	No	No	Current