acyclovir

Product NDC: 60505-5307
11-digit product format: 605055307
Labeler code: 60505
Product ID: 60505-5307_99d0802e-98ae-2322-114d-9a06593c2dc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA077309
Marketing category: ANDA
Marketing start: 2006-03-13
Marketing end: 2026-12-31
Substance: ACYCLOVIR
Active strength: 800 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

Additional Listing Data#

Finished product: Yes
Brand name base: acyclovir

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	800 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	X4HES1O11F
Rxcui	197311, 197313

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
60505-5307-1	acyclovir	100 in 1 BOTTLE	TABLET	100	7
60505-5307-3	acyclovir	30 in 1 BOTTLE	TABLET	30	7
60505-5307-5	acyclovir	500 in 1 BOTTLE	TABLET	500	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-5307-1	EA - Each	60505-5307	6fb8b9ce-27c8-4fd5-a555-01bb1270f778	1	2012-07-24
60505-5307-5	EA - Each	60505-5307	aa02fe67-d9b4-424f-85c8-040bddb626e7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [APOTEX CORP.]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [APOTEX CORP.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [APOTEX CORP.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR TABLET [APOTEX CORP.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [PROFICIENT RX LP]	2
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [APOTEX CORP.]	2
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-5307	ACYCLOVIR TABLET [APOTEX CORP.]	6	Current NDC, Legacy NDC, 3 package rows	20240425_7fdeb609-24c4-5024-52c3-6a32bc7f3fcc.zip

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
197313	acyclovir 800 MG Oral Tablet	PSN	bf1b4142-c5f3-4147-8224-bf6344566694	105
197313	acyclovir 800 MG Oral Tablet	SCD	bf1b4142-c5f3-4147-8224-bf6344566694	105
197313	acycycloguanosine 800 MG Oral Tablet	SY	bf1b4142-c5f3-4147-8224-bf6344566694	105
197313	acyclovir 800 MG Oral Tablet	PSN	a7fd298b-3914-4316-8484-2d3ae188221a	102
197313	acyclovir 800 MG Oral Tablet	SCD	a7fd298b-3914-4316-8484-2d3ae188221a	102
197313	acycycloguanosine 800 MG Oral Tablet	SY	a7fd298b-3914-4316-8484-2d3ae188221a	102
197313	acyclovir 800 MG Oral Tablet	PSN	6952db57-c3a3-46a4-828c-21e9eccd22f0	10
197313	acyclovir 800 MG Oral Tablet	SCD	6952db57-c3a3-46a4-828c-21e9eccd22f0	10
197313	acycycloguanosine 800 MG Oral Tablet	SY	6952db57-c3a3-46a4-828c-21e9eccd22f0	10
197311	acyclovir 400 MG Oral Tablet	PSN	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197313	acyclovir 800 MG Oral Tablet	PSN	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197313	acyclovir 800 MG Oral Tablet	PSN	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7
197311	acyclovir 400 MG Oral Tablet	SCD	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197313	acyclovir 800 MG Oral Tablet	SCD	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7
197313	acyclovir 800 MG Oral Tablet	SCD	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197311	acycycloguanosine 400 MG Oral Tablet	SY	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197313	acycycloguanosine 800 MG Oral Tablet	SY	d92e83ee-b513-487d-b0b2-8287ffd2bc26	7
197313	acycycloguanosine 800 MG Oral Tablet	SY	7fdeb609-24c4-5024-52c3-6a32bc7f3fcc	7
197313	acyclovir 800 MG Oral Tablet	PSN	4c5a75fa-73db-4f48-895f-de1635d33f49	4
197313	acyclovir 800 MG Oral Tablet	PSN	271bfbb6-4990-500a-e054-00144ff8d46c	4
197313	acyclovir 800 MG Oral Tablet	SCD	271bfbb6-4990-500a-e054-00144ff8d46c	4
197313	acyclovir 800 MG Oral Tablet	SCD	4c5a75fa-73db-4f48-895f-de1635d33f49	4
197313	acycycloguanosine 800 MG Oral Tablet	SY	4c5a75fa-73db-4f48-895f-de1635d33f49	4
197313	acycycloguanosine 800 MG Oral Tablet	SY	271bfbb6-4990-500a-e054-00144ff8d46c	4
197313	acyclovir 800 MG Oral Tablet	PSN	968800dc-9456-a45f-e053-2995a90aa15e	3
197313	acyclovir 800 MG Oral Tablet	PSN	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3
197313	acyclovir 800 MG Oral Tablet	PSN	db35fce0-d7a3-4589-ba60-d78cdb1119cb	3
197313	acyclovir 800 MG Oral Tablet	SCD	968800dc-9456-a45f-e053-2995a90aa15e	3
197313	acyclovir 800 MG Oral Tablet	SCD	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3
197313	acyclovir 800 MG Oral Tablet	SCD	db35fce0-d7a3-4589-ba60-d78cdb1119cb	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	968800dc-9456-a45f-e053-2995a90aa15e	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	4e2d06ed-7b2f-26d5-e054-00144ff88e88	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	db35fce0-d7a3-4589-ba60-d78cdb1119cb	3
197313	acyclovir 800 MG Oral Tablet	PSN	495bb417-880e-4af0-9374-c2ef7ae82c7b	1
197313	acyclovir 800 MG Oral Tablet	SCD	495bb417-880e-4af0-9374-c2ef7ae82c7b	1
197313	acycycloguanosine 800 MG Oral Tablet	SY	495bb417-880e-4af0-9374-c2ef7ae82c7b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-5307-1	60505530701	100 TABLET in 1 BOTTLE (60505-5307-1)	100 tablet	2006-03-13	2026-12-31	No	No	Current
60505-5307-3	60505530703	30 TABLET in 1 BOTTLE (60505-5307-3)	30 tablet	2006-03-13	0000-00-00	No	No	Current
60505-5307-5	60505530705	500 TABLET in 1 BOTTLE (60505-5307-5)	500 tablet	2006-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Apotex Corp. \| Apotex Inc.	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	7
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	102
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Bryant Ranch Prepack	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	3
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	105
ACYCLOVIR	DIRECT RX	2023-03-29	HUMAN PRESCRIPTION DRUG LABEL	7
acyclovir - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	A-S Medication Solutions	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL	10
ACYCLOVIR TABLETS USP 400 MG AND 800 MG	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Liberty Pharmaceuticals, Inc.	2016-08-12	HUMAN PRESCRIPTION DRUG LABEL	1
ACYCLOVIR TABLETS USP 400 MG AND 800 MG	Apotheca Inc. \| Apotheca Inc	2015-12-17	HUMAN PRESCRIPTION DRUG LABEL	4

acyclovir

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#