ACYCLOVIR

Product NDC: 55154-7629
11-digit product format: 551547629
Labeler code: 55154
Product ID: 55154-7629_9534442e-046a-4f0e-a938-c49cd1481bbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: CAPSULE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA075677
Marketing category: ANDA
Marketing start: 2007-04-19
Marketing end: 2026-08-31
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
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
A075677-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075677-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075677-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	RS	2005-09-28	`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	A075677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075677-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075677-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075677-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075677-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075677-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACYCLOVIR

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
7484b631-18f9-440d-bb11-a44932fec6e7	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
55154-7629-0	ACYCLOVIR	1 in 1 BLISTER PACK	CAPSULE	1		15
55154-7629-0	ACYCLOVIR	10 in 1 BAG	CAPSULE	10		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-7629	ACYCLOVIR CAPSULE [CARDINAL HEALTH 107, LLC]	13	Current NDC, Legacy NDC, 2 package rows	20240606_7484b631-18f9-440d-bb11-a44932fec6e7.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	Bryant Ranch Prepack	2b600b5d-ce91-461f-b9d1-75b969daf8e9	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Major Pharmaceuticals	864d96b9-e2de-45a8-850b-6f7b72ceefe1	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Cardinal Health 107, LLC	7484b631-18f9-440d-bb11-a44932fec6e7	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677 ndc (product): 55154-7629
ACYCLOVIR	ACYCLOVIR	Bryant Ranch Prepack	e5356160-cb35-4ff6-91d5-2ade594e0279	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Apotex Corp.	41bea43a-f58c-2c6f-4d31-406ceb456077	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677
ACYCLOVIR	ACYCLOVIR	Proficient Rx LP	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	2020-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075677 application number: ANDA075677

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	7484b631-18f9-440d-bb11-a44932fec6e7	15
197310	acyclovir 200 MG Oral Capsule	SCD	7484b631-18f9-440d-bb11-a44932fec6e7	15
197310	acycycloguanosine 200 MG Oral Capsule	SY	7484b631-18f9-440d-bb11-a44932fec6e7	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-7629-0	55154762900	10 BLISTER PACK in 1 BAG (55154-7629-0) / 1 CAPSULE in 1 BLISTER PACK	10 blister pack	2007-04-19	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES USP 200 mg	Cardinal Health 107, LLC	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	15