ACYCLOVIR

Product NDC: 60505-0042
11-digit product format: 605050042
Labeler code: 60505
Product ID: 60505-0042_ca931d58-7d38-8516-2997-f61253819cb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075677
Marketing category: ANDA
Marketing start: 2006-03-20
Marketing end: 2027-04-30
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

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	60505-0042	60505-0042-5	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
41bea43a-f58c-2c6f-4d31-406ceb456077	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
60505-0042-5	ACYCLOVIR	500 in 1 BOTTLE	CAPSULE	500		8
60505-0042-6	ACYCLOVIR	100 in 1 BOTTLE	CAPSULE	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0042-6	EA - Each	60505-0042	acc06317-f0ea-434e-8d73-02361df47473	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACYCLOVIR CAPSULE [APOTEX CORP.]	2
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACYCLOVIR CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0042	ACYCLOVIR CAPSULE [APOTEX CORP.]	7	Current NDC, Legacy NDC, 2 package rows	20240516_41bea43a-f58c-2c6f-4d31-406ceb456077.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
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 ndc (product): 60505-0042
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	e5356160-cb35-4ff6-91d5-2ade594e0279	102
197310	acyclovir 200 MG Oral Capsule	SCD	e5356160-cb35-4ff6-91d5-2ade594e0279	102
197310	acycycloguanosine 200 MG Oral Capsule	SY	e5356160-cb35-4ff6-91d5-2ade594e0279	102
197310	acyclovir 200 MG Oral Capsule	PSN	0fbc0612-0249-481d-8198-0e810423f875	9
197310	acyclovir 200 MG Oral Capsule	PSN	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9
197310	acyclovir 200 MG Oral Capsule	SCD	0fbc0612-0249-481d-8198-0e810423f875	9
197310	acyclovir 200 MG Oral Capsule	SCD	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9
197310	acycycloguanosine 200 MG Oral Capsule	SY	0fbc0612-0249-481d-8198-0e810423f875	9
197310	acycycloguanosine 200 MG Oral Capsule	SY	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9
197310	acyclovir 200 MG Oral Capsule	PSN	41bea43a-f58c-2c6f-4d31-406ceb456077	8
197310	acyclovir 200 MG Oral Capsule	SCD	41bea43a-f58c-2c6f-4d31-406ceb456077	8
197310	acycycloguanosine 200 MG Oral Capsule	SY	41bea43a-f58c-2c6f-4d31-406ceb456077	8
197310	acyclovir 200 MG Oral Capsule	PSN	2b600b5d-ce91-461f-b9d1-75b969daf8e9	7
197310	acyclovir 200 MG Oral Capsule	SCD	2b600b5d-ce91-461f-b9d1-75b969daf8e9	7
197310	acycycloguanosine 200 MG Oral Capsule	SY	2b600b5d-ce91-461f-b9d1-75b969daf8e9	7
197310	acyclovir 200 MG Oral Capsule	PSN	7ee2d439-e78d-42ac-b93e-aa5e2656fb82	5
197310	acyclovir 200 MG Oral Capsule	PSN	4e8f535c-057d-0ddf-e054-00144ff8d46c	5
197310	acyclovir 200 MG Oral Capsule	SCD	7ee2d439-e78d-42ac-b93e-aa5e2656fb82	5
197310	acyclovir 200 MG Oral Capsule	SCD	4e8f535c-057d-0ddf-e054-00144ff8d46c	5
197310	acycycloguanosine 200 MG Oral Capsule	SY	7ee2d439-e78d-42ac-b93e-aa5e2656fb82	5
197310	acycycloguanosine 200 MG Oral Capsule	SY	4e8f535c-057d-0ddf-e054-00144ff8d46c	5
197310	acyclovir 200 MG Oral Capsule	PSN	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	3
197310	acyclovir 200 MG Oral Capsule	SCD	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	3
197310	acycycloguanosine 200 MG Oral Capsule	SY	8d7994a6-5bd2-494d-89c1-b03755d4f2c3	3
197310	acyclovir 200 MG Oral Capsule	PSN	8e6e3ffb-a884-ec6b-e053-2a95a90a6dda	1
197310	acyclovir 200 MG Oral Capsule	SCD	8e6e3ffb-a884-ec6b-e053-2a95a90a6dda	1
197310	acycycloguanosine 200 MG Oral Capsule	SY	8e6e3ffb-a884-ec6b-e053-2a95a90a6dda	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0042-5	60505004205	500 CAPSULE in 1 BOTTLE (60505-0042-5)	500 capsule	2006-03-20	0000-00-00	No	No	Current
60505-0042-6	60505004206	100 CAPSULE in 1 BOTTLE (60505-0042-6)	100 capsule	2006-03-20	2027-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES USP 200 mg	Bryant Ranch Prepack	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	7
ACYCLOVIR CAPSULES USP 200 mg	Major Pharmaceuticals	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	9
ACYCLOVIR CAPSULES USP 200 mg	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	102
ACYCLOVIR CAPSULES USP 200 mg	Apotex Corp. \| Apotex Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	8
ACYCLOVIR CAPSULES USP 200 mg	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	14
ACYCLOVIR CAPSULES USP 200 mg	St. Mary's Medical Park Pharmacy	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	6
Acyclovir Capsules USP 8210701/0813A Rx only	American Health Packaging	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	7
Acyclovir Capsules USP Rx Only	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
ACYCLOVIR CAPSULES USP 200 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
ACYCLOVIR - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	5
ACYCLOVIR CAPSULES USP 200 mg	Proficient Rx LP	2020-12-01	HUMAN PRESCRIPTION DRUG LABEL	3
ACYCLOVIR CAPSULES USP 200 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
ACYCLOVIR CAPSULES USP 200 mg	Golden State Medical Supply, Inc.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	6
ACYCLOVIR	Direct_Rx \| ACYCLOVIR	2019-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
ACYCLOVIR CAPSULES USP 200 mg	REMEDYREPACK INC.	2019-03-07	HUMAN PRESCRIPTION DRUG LABEL	4
ACYCLOVIR CAPSULES USP 200 mg	A-S Medication Solutions	2019-01-24	HUMAN PRESCRIPTION DRUG LABEL	9
ACYCLOVIR CAPSULES USP 200 mg	NuCare Pharmaceuticals,Inc.	2018-12-06	HUMAN PRESCRIPTION DRUG LABEL	2