Acyclovir

Product NDC: 31722-778
11-digit product format: 317220778
Labeler code: 31722
Product ID: 31722-778_49d4285f-03ac-75ae-e063-6294a90a0da0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA203834
Marketing category: ANDA
Marketing start: 2013-11-29
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Acyclovir
Listing expiration: 2027-12-31

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	Strength	SPL version
31722-778-01	Acyclovir	100 in 1 BOTTLE	TABLET	100		4
31722-778-05	Acyclovir	500 in 1 BOTTLE	TABLET	500		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]	4
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [DIRECT RX]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACYCLOVIR TABLET [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACYCLOVIR TABLET [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-778	ACYCLOVIR (ACYCLOVIR) TABLET [CAMBER PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20210407_0910335b-6796-459f-b97e-d7ef5439a060.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	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102
197313	acyclovir 800 MG Oral Tablet	SCD	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102
197313	acycycloguanosine 800 MG Oral Tablet	SY	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	102
197313	acyclovir 800 MG Oral Tablet	PSN	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	17
197313	acyclovir 800 MG Oral Tablet	SCD	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	17
197313	acycycloguanosine 800 MG Oral Tablet	SY	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	17
197313	acyclovir 800 MG Oral Tablet	PSN	736679be-469e-4bdb-8e15-b10751c3dd60	11
197313	acyclovir 800 MG Oral Tablet	SCD	736679be-469e-4bdb-8e15-b10751c3dd60	11
197313	acycycloguanosine 800 MG Oral Tablet	SY	736679be-469e-4bdb-8e15-b10751c3dd60	11
197313	acyclovir 800 MG Oral Tablet	PSN	b6d69697-12bb-4548-a6c3-2463cbf54f8f	7
197313	acyclovir 800 MG Oral Tablet	SCD	b6d69697-12bb-4548-a6c3-2463cbf54f8f	7
197313	acycycloguanosine 800 MG Oral Tablet	SY	b6d69697-12bb-4548-a6c3-2463cbf54f8f	7
197313	acyclovir 800 MG Oral Tablet	PSN	9e5b3a11-9c4b-4998-8a18-3046af1314ab	6
197313	acyclovir 800 MG Oral Tablet	SCD	9e5b3a11-9c4b-4998-8a18-3046af1314ab	6
197313	acycycloguanosine 800 MG Oral Tablet	SY	9e5b3a11-9c4b-4998-8a18-3046af1314ab	6
197313	acyclovir 800 MG Oral Tablet	PSN	b004baf0-3178-4ced-9917-be87d0b4e833	5
197313	acyclovir 800 MG Oral Tablet	PSN	b398875e-1150-4a02-a867-6e9853b9ff12	5
197313	acyclovir 800 MG Oral Tablet	PSN	5176c7f9-9076-4797-e054-00144ff8d46c	5
197313	acyclovir 800 MG Oral Tablet	SCD	5176c7f9-9076-4797-e054-00144ff8d46c	5
197313	acyclovir 800 MG Oral Tablet	SCD	b398875e-1150-4a02-a867-6e9853b9ff12	5
197313	acyclovir 800 MG Oral Tablet	SCD	b004baf0-3178-4ced-9917-be87d0b4e833	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	5176c7f9-9076-4797-e054-00144ff8d46c	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	b398875e-1150-4a02-a867-6e9853b9ff12	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	b004baf0-3178-4ced-9917-be87d0b4e833	5
197311	acyclovir 400 MG Oral Tablet	PSN	0910335b-6796-459f-b97e-d7ef5439a060	4
197313	acyclovir 800 MG Oral Tablet	PSN	0910335b-6796-459f-b97e-d7ef5439a060	4
197311	acyclovir 400 MG Oral Tablet	SCD	0910335b-6796-459f-b97e-d7ef5439a060	4
197313	acyclovir 800 MG Oral Tablet	SCD	0910335b-6796-459f-b97e-d7ef5439a060	4
197311	acycycloguanosine 400 MG Oral Tablet	SY	0910335b-6796-459f-b97e-d7ef5439a060	4
197313	acycycloguanosine 800 MG Oral Tablet	SY	0910335b-6796-459f-b97e-d7ef5439a060	4
197313	acyclovir 800 MG Oral Tablet	PSN	4fd2fd45-e5a4-291a-e054-00144ff88e88	3
197313	acyclovir 800 MG Oral Tablet	PSN	f6f56143-ea74-af87-e053-6394a90ae346	3
197313	acyclovir 800 MG Oral Tablet	SCD	4fd2fd45-e5a4-291a-e054-00144ff88e88	3
197313	acyclovir 800 MG Oral Tablet	SCD	f6f56143-ea74-af87-e053-6394a90ae346	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	4fd2fd45-e5a4-291a-e054-00144ff88e88	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	f6f56143-ea74-af87-e053-6394a90ae346	3
197313	acyclovir 800 MG Oral Tablet	PSN	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2
197313	acyclovir 800 MG Oral Tablet	SCD	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2
197313	acycycloguanosine 800 MG Oral Tablet	SY	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2
197313	acyclovir 800 MG Oral Tablet	PSN	1493e22d-455d-b613-e063-6294a90afede	1
197313	acyclovir 800 MG Oral Tablet	SCD	1493e22d-455d-b613-e063-6294a90afede	1
197313	acycycloguanosine 800 MG Oral Tablet	SY	1493e22d-455d-b613-e063-6294a90afede	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-778-01	31722077801	100 TABLET in 1 BOTTLE (31722-778-01)	100 tablet	2013-11-29	0000-00-00	No	No	Current
31722-778-05	31722077805	500 TABLET in 1 BOTTLE (31722-778-05)	500 tablet	2013-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets, USP Rx only	Bryant Ranch Prepack	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	103
PRESCRIBING INFORMATION Acyclovir Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	17
PRESCRIBING INFORMATION Acyclovir Tablets, USP Rx only	Preferred Pharmaceuticals, Inc.	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	7
PRESCRIBING INFORMATION Acyclovir Tablets, USP Rx only	REMEDYREPACK INC.	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	11
PRESCRIBING INFORMATION Acyclovir Tablets, USP Rx only	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	4
Acyclovir Tablets, USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Acyclovir Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir Tablets, USP Rx only	ST. MARY'S MEDICAL PARK PHARMACY	2024-03-26	HUMAN PRESCRIPTION DRUG LABEL	1
Acyclovir Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir	Direct Rx	2023-04-27	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir Tablets, USP Rx only	PharmPak, Inc.	2022-10-09	HUMAN PRESCRIPTION DRUG LABEL	2
Acyclovir Tablets, USP Rx only	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	6
Acyclovir - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3

Acyclovir

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#