Acyclovir

Product NDC: 75834-124
11-digit product format: 758340124
Labeler code: 75834
Product ID: 75834-124_bdd7c1ab-7f2d-43b5-9ff7-238aa1b9576f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA201445
Marketing category: ANDA
Marketing start: 2016-10-15
Substance: ACYCLOVIR
Active strength: 200 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75834-124		D	Discontinued by firm	2026-09-09
excluded package	package	75834-124	75834-124-01	D	Discontinued by firm	2026-09-09
excluded package	package	75834-124	75834-124-05	D	Discontinued by firm	2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201445-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2014-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201445-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201445-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2014-03-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201445-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201445-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201445-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201445-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201445-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201445-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201445-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201445-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201445-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201445-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201445-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201445-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201445-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201445-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201445-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201445-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201445-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201445-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201445-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201445-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201445-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201445-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201445-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201445-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201445-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201445-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201445-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201445-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201445-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201445-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201445-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201445-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201445-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201445-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201445-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201445-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201445-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201445-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201445-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201445-001	AB	1	`e64feba35796…`

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
75834-124-01	2022-02-15	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-05	2022-02-15	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-01	2022-01-28	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-05	2022-01-28	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-01	2020-05-05	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-05	2020-05-05	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-01	2020-01-31	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-05	2020-01-31	Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75834-124-01	Acyclovir	100 in 1 BOTTLE	CAPSULE	100		4
75834-124-05	Acyclovir	500 in 1 BOTTLE	CAPSULE	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-124-01	EA - Each	75834-124	df9410d3-1d2a-4551-85ab-71675d863ddb	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-124	ACYCLOVIR CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20220216_1b0919aa-0d41-4c91-9ef4-049ac9e27d78.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Modavar Pharmaceuticals LLC	c7317324-4654-4bcc-8edf-7b7cd8794d2e	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201445 application number: ANDA201445
Acyclovir	ACYCLOVIR	Cadila Pharmaceuticals Limited	dbaf4bf5-57e3-4770-a9b2-d47649e54c1b	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201445 application number: ANDA201445

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
197310	acyclovir 200 MG Oral Capsule	PSN	1b0919aa-0d41-4c91-9ef4-049ac9e27d78	4
197310	acyclovir 200 MG Oral Capsule	PSN	1dc4a821-b0d6-433c-94f4-61c1a479102a	4
197310	acyclovir 200 MG Oral Capsule	SCD	1b0919aa-0d41-4c91-9ef4-049ac9e27d78	4
197310	acyclovir 200 MG Oral Capsule	SCD	1dc4a821-b0d6-433c-94f4-61c1a479102a	4
197310	acycycloguanosine 200 MG Oral Capsule	SY	1b0919aa-0d41-4c91-9ef4-049ac9e27d78	4
197310	acycycloguanosine 200 MG Oral Capsule	SY	1dc4a821-b0d6-433c-94f4-61c1a479102a	4
197310	acyclovir 200 MG Oral Capsule	PSN	9718e55a-433b-6bad-e053-2a95a90af125	3
197310	acyclovir 200 MG Oral Capsule	SCD	9718e55a-433b-6bad-e053-2a95a90af125	3
197310	acycycloguanosine 200 MG Oral Capsule	SY	9718e55a-433b-6bad-e053-2a95a90af125	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-124-01	75834012401	100 CAPSULE in 1 BOTTLE (75834-124-01)	100 capsule	2016-10-15	0000-00-00	No	No	Current
75834-124-05	75834012405	500 CAPSULE in 1 BOTTLE (75834-124-05)	500 capsule	2016-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir 200mg	RedPharm Drug, Inc.	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	3
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	Bryant Ranch Prepack	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	4
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	Nivagen Pharmaceuticals, Inc.	2022-02-15	HUMAN PRESCRIPTION DRUG LABEL	4
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	A-S Medication Solutions	2021-09-29	HUMAN PRESCRIPTION DRUG LABEL	1
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	2021-03-15	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.	REMEDYREPACK INC.	2020-05-13	HUMAN PRESCRIPTION DRUG LABEL	4