acyclovir

Product NDC: 71335-2261
Requested package NDC: 71335-2261-8
11-digit product format: 713352261
Labeler code: 71335
Product ID: 71335-2261_1bed7dd6-b341-487f-8cdb-45c1d7906e32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204313
Marketing category: ANDA
Marketing start: 2019-08-23
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204313-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204313-001	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 · 41 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	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2016-03-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204313-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204313-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204313-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204313-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204313-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204313-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204313-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204313-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204313-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204313-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204313-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204313-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204313-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204313-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204313-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204313-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204313-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204313-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204313-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204313-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204313-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204313-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204313-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204313-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204313-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204313-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204313-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204313-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204313-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204313-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204313-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204313-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204313-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204313-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204313-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204313-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204313-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204313-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204313-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204313-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: acyclovir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	200 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
197310	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
c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2261-0	acyclovir	90 in 1 BOTTLE	CAPSULE	90	101
71335-2261-1	acyclovir	30 in 1 BOTTLE	CAPSULE	30	101
71335-2261-2	acyclovir	25 in 1 BOTTLE	CAPSULE	25	101
71335-2261-3	acyclovir	35 in 1 BOTTLE	CAPSULE	35	101
71335-2261-4	acyclovir	50 in 1 BOTTLE	CAPSULE	50	101
71335-2261-5	acyclovir	100 in 1 BOTTLE	CAPSULE	100	101
71335-2261-6	acyclovir	40 in 1 BOTTLE	CAPSULE	40	101
71335-2261-7	acyclovir	60 in 1 BOTTLE	CAPSULE	60	101
71335-2261-8	acyclovir	120 in 1 BOTTLE	CAPSULE	120	101
71335-2261-9	acyclovir	20 in 1 BOTTLE	CAPSULE	20	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2261	ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]	100	Current NDC, 10 package rows	20231031_c818e86c-a4d0-48cd-a888-fa1ee9e2aa19.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	86c43bdf-c5bf-47cd-8dfd-811263825878	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Proficient Rx LP	d4729677-164b-41b8-bbc4-4e47346b0f72	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	REMEDYREPACK INC.	0990b625-5dfe-4810-b5b4-ac5948599e79	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	A-S Medication Solutions	a0ed999f-7366-42c3-a6f5-3c239215a99c	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Northwind Health Company, LLC	ff9776b3-a248-e1ea-e053-6294a90aeb7b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	e580b7e9-9060-43f5-9b58-33998078d7e4	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	395cd839-21e1-43e2-a8ce-078f07bc7668	2025-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313
acyclovir	ACYCLOVIR	Bryant Ranch Prepack	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313 ndc (package): 71335-2261-8 ndc (product): 71335-2261 ndc11 (package): 71335226108
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4	2025-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204313 application number: ANDA204313

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	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	101
197310	acyclovir 200 MG Oral Capsule	SCD	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	101
197310	acycycloguanosine 200 MG Oral Capsule	SY	c818e86c-a4d0-48cd-a888-fa1ee9e2aa19	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2261-8	71335226108	120 CAPSULE in 1 BOTTLE (71335-2261-8)	120 capsule	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Capsules, USP Rx only	Bryant Ranch Prepack	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	101