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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203834-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29
A203834-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203834-001	AB
A203834-002	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 3 · 82 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	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB		2013-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203834-001	ACYCLOVIR	400MG	TABLET / ORAL	AB		2013-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203834-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	RS	2013-10-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203834-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203834-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203834-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203834-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203834-002	AB	1	`782e0a99824c…`

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 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197311	Internal RxNorm lookup
197313	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
0910335b-6796-459f-b97e-d7ef5439a060	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
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

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	6d0e492e-5359-49e8-812d-8c8e2e5d42f8	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	736679be-469e-4bdb-8e15-b10751c3dd60	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	REMEDYREPACK INC.	38547daa-7d2f-4a7b-84d3-6e164984f958	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	St. Mary's Medical Park Pharmacy	1493e22d-455d-b613-e063-6294a90afede	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	dbdb7903-0991-413d-b1ad-ab0f1ae2d8f4	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	0e78d5e8-ae2d-4e84-b8c2-6765b1299c12	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PD-Rx Pharmaceuticals, Inc.	e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Major Pharmaceuticals	46150f19-ce5d-42a0-80a7-f96fda2b9879	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Preferred Pharmaceuticals, Inc.	b6d69697-12bb-4548-a6c3-2463cbf54f8f	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Camber Pharmaceuticals, Inc.	0910335b-6796-459f-b97e-d7ef5439a060	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834 ndc (product): 31722-778
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	5dcfd21c-43f0-469c-be70-a4e74e6ccf88	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Northwind Health Company, LLC	f6f56143-ea74-af87-e053-6394a90ae346	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	Advanced Rx Pharmacy of Tennessee, LLC	f4c5779d-e4bf-4f2b-e053-2995a90a9187	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	638803d2-a172-486d-e053-2991aa0ab074	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals, Inc.	5176c7f9-9076-4797-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	83e82707-85b6-2fea-e053-2991aa0a99ef	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	A-S Medication Solutions	e4f91376-9e18-41a4-aa5e-adcea0c625d9	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	d824fc07-9f03-4cb2-9bf8-ff7cc2955255	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834
Acyclovir	ACYCLOVIR	PharmPak, Inc.	8fb01f23-e2bd-6850-e053-2995a90a7cc5	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203834 application number: ANDA203834

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
PRESCRIBING INFORMATION Acyclovir Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	12
Acyclovir Tablets, USP Rx only	Bryant Ranch Prepack	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	103
Acyclovir Tablets, USP Rx only	St. Mary's Medical Park Pharmacy	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
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	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	A-S Medication Solutions	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	28
Acyclovir Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	5
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	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	1
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 Tablets, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-11-23	HUMAN PRESCRIPTION DRUG LABEL	3
Acyclovir Tablets, USP Rx only	Quality Care Products, LLC	2021-04-16	Human Prescription Drug Label	2