Application 074891

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	400MG	No	No
002	ACYCLOVIR	ACYCLOVIR	TABLET;ORAL	800MG	No	No

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…`

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 ndc (product): 68071-2279
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 ndc (product): 71335-1645
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 (product): 71335-1757
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 ndc (product): 23155-227 ndc (product): 23155-228
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 ndc (product): 71205-388 ndc (product): 71205-371

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-227	ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-227	ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-227	Acyclovir	Acyclovir	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-228	ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-228	ACYCLOVIR	ACYCLOVIR	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-228	Acyclovir	Acyclovir	Heritage Pharmaceuticals Inc.	ANDA	Current
68071-2279	ACYCLOVIR	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2279	ACYCLOVIR	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5122	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5122	Acyclovir	Acyclovir	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2085	Acyclovir	Acyclovir	REMEDYREPACK INC.	ANDA	Current
70934-465	ACYCLOVIR	ACYCLOVIR	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-511	ACYCLOVIR	ACYCLOVIR	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-512	Acyclovir	Acyclovir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-512	ACYCLOVIR	ACYCLOVIR	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-532	ACYCLOVIR	ACYCLOVIR	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-371	ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	ANDA	Current
71205-388	ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	ANDA	Current
71335-1645	ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	ANDA	Current
71335-1645	ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	ANDA	Current
71335-1757	ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	ANDA	Current
71335-1757	ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42893	ORIG	2007-07-06