Acyclovir

Product NDC: 68071-2299
11-digit product format: 680712299
Labeler code: 68071
Product ID: 68071-2299_1d785fd9-da01-92dd-e063-6294a90a9c1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA206261
Marketing category: ANDA
Marketing start: 2017-08-17
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
A206261-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		2017-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206261-001	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	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	2017-08-16	`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	A206261-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206261-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206261-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206261-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206261-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206261-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206261-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206261-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206261-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206261-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206261-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206261-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206261-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206261-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206261-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206261-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206261-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206261-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206261-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206261-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206261-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206261-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206261-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206261-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206261-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206261-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206261-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206261-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206261-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206261-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206261-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206261-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206261-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206261-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206261-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206261-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206261-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206261-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206261-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206261-001	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
b455053f-3deb-bd76-e053-2a95a90a9869	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	Strength	SPL version
68071-2299-3	Acyclovir	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2299	ACYCLOVIR CAPSULE [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240719_b455053f-3deb-bd76-e053-2a95a90a9869.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	0d99ba77-c3c5-1fd0-e063-6294a90a6f2a	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	af9d41f5-4658-4487-8811-32a1f8af9384	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	01ae85df-d1a0-44f7-b4c0-0ac74d2216d4	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	37499620-6a17-40f1-b0db-dd79320ea21d	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	b455053f-3deb-bd76-e053-2a95a90a9869	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261 ndc (product): 68071-2299
Acyclovir	ACYCLOVIR	Proficient Rx LP	e8056ec6-d2dc-48af-8550-82726af1c5c5	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206261 application number: ANDA206261

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	b455053f-3deb-bd76-e053-2a95a90a9869	3
197310	acyclovir 200 MG Oral Capsule	SCD	b455053f-3deb-bd76-e053-2a95a90a9869	3
197310	acycycloguanosine 200 MG Oral Capsule	SY	b455053f-3deb-bd76-e053-2a95a90a9869	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2299-3	68071229903	30 CAPSULE in 1 BOTTLE, PLASTIC (68071-2299-3)	30 capsule	2020-11-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION Acyclovir Capsules USP	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3