ACYCLOVIR

Product NDC: 61919-003
Requested package NDC: 61919-003-30
11-digit product format: 619190003
Labeler code: 61919
Product ID: 61919-003_f21b560f-f5c1-2bfb-e053-2a95a90aa353
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA077309
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: ACYCLOVIR
Active strength: 800 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: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-003	61919-003-30	I	Inactivated by FDA		2026-08-11

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A077309-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2005-09-29
A077309-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		2005-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077309-001	AB
A077309-002	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	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077309-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	2005-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077309-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	2005-09-29	`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	A077309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077309-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077309-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077309-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077309-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077309-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077309-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077309-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077309-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077309-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077309-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077309-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077309-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077309-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077309-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077309-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077309-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077309-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077309-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077309-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077309-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077309-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077309-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077309-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077309-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077309-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077309-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077309-002	AB	1	`782e0a99824c…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-003-30	2025-01-30	C162847	48780-1	2cef2736-6357-d83d-e063-dadaa90ab31f	ACYCLOVIR
61919-003-35	2025-01-30	C162847	48780-1	2cef2736-6357-d83d-e063-dadaa90ab31f	ACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-003-30	ACYCLOVIR	30 in 1 BOTTLE	TABLET	30		7
61919-003-35	ACYCLOVIR	35 in 1 BOTTLE	TABLET	35		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-003-35	EA - Each	61919-003	13a299f5-bdc7-408f-9712-72912ba11f9d	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-003	ACYCLOVIR TABLET [DIRECT RX]	7	Legacy NDC, 2 package rows	20230331_d92e83ee-b513-487d-b0b2-8287ffd2bc26.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	499c6a98-0614-4ded-8526-909942bae8a4	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	db35fce0-d7a3-4589-ba60-d78cdb1119cb	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Apotex Corp.	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	a7fd298b-3914-4316-8484-2d3ae188221a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	ada4004a-c10a-6190-e053-2a95a90a5e67	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b2ae0432-bd2a-1480-e053-2a95a90a6fc8	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	968800dc-9456-a45f-e053-2995a90aa15e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	bf1b4142-c5f3-4147-8224-bf6344566694	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Proficient Rx LP	4c5a75fa-73db-4f48-895f-de1635d33f49	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Asclemed USA, Inc.	e186fdc9-b60e-4280-8d60-36cae9f2838f	2020-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309
acyclovir	ACYCLOVIR	Proficient Rx LP	51052f0e-1a07-405a-a962-981ce9439e02	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077309 application number: ANDA077309

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
197313	acyclovir 800 MG Oral Tablet	PSN	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7
197313	acyclovir 800 MG Oral Tablet	SCD	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7
197313	acycycloguanosine 800 MG Oral Tablet	SY	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-003-30	61919000330	30 TABLET in 1 BOTTLE (61919-003-30)	30 tablet	2014-01-01	0000-00-00	No	No	Current