Acyclovir

Product NDC: 61442-113
11-digit product format: 614420113
Labeler code: 61442
Product ID: 61442-113_209d3251-8d40-86dc-e063-6394a90a3492
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Carlsbad Technology, Inc.
Application: ANDA075382
Marketing category: ANDA
Marketing start: 2009-10-22
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: 2026-12-31
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
A075382-001	ACYCLOVIR	ACYCLOVIR	400MG	TABLET / ORAL	AB		1999-04-30
A075382-002	ACYCLOVIR	ACYCLOVIR	800MG	TABLET / ORAL	AB		1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075382-001	AB
A075382-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075382-001	ACYCLOVIR	400MG	TABLET / ORAL	AB	1999-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075382-002	ACYCLOVIR	800MG	TABLET / ORAL	AB	1999-04-30	`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	A075382-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075382-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075382-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075382-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075382-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075382-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075382-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075382-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075382-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075382-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075382-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075382-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075382-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075382-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075382-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075382-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075382-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075382-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075382-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075382-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075382-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075382-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075382-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075382-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075382-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075382-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075382-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075382-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075382-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acyclovir
Listing expiration: 2026-12-31

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
a68e610a-841c-4b69-9233-673d060561e8	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61442-113-01	2020-02-02	Acyclovir Tablets USP
61442-113-05	2020-02-02	Acyclovir Tablets USP
61442-113-01	2020-01-31	Acyclovir Tablets USP
61442-113-05	2020-01-31	Acyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61442-113-01	Acyclovir	24 in 1 BOX	TABLET	24	9
61442-113-01	Acyclovir	100 in 1 BOTTLE, PLASTIC	TABLET	100	9
61442-113-05	Acyclovir	500 in 1 BOTTLE, PLASTIC	TABLET	500	9
61442-113-05	Acyclovir	12 in 1 BOX	TABLET	12	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61442-113-01	EA - Each	61442-113	abc21be5-d6b8-4f73-9330-b70c48e1bf7a	1	2012-07-24
61442-113-05	EA - Each	61442-113	afa8952f-c4ff-43be-8ef0-8c2bf72fa892	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]	11
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	4
Acyclovir	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
acyclovir	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]	3
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACYCLOVIR TABLET [BRYANT RANCH PREPACK]	2
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61442-113	ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240828_a68e610a-841c-4b69-9233-673d060561e8.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Cardinal Health 107, LLC	d8004652-86fe-4714-81d4-5e1dd2585bb4	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	AvPAK	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f3cbd634-77c8-3306-bdbd-a4598b20603e	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e0f17e6f-63c7-4828-8585-91fc582df30b	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	8c5d1f30-2d31-417d-860b-7228b7baaa64	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Golden State Medical Supply, Inc.	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	89583890-186b-4a7a-8741-41f6c5f0a99d	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Carlsbad Technology, Inc.	a68e610a-841c-4b69-9233-673d060561e8	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382 ndc (product): 61442-113
Acyclovir	ACYCLOVIR	NuCare Pharmaceuticals,Inc.	c46d5033-b1b2-e213-e053-2995a90ae6a3	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382
Acyclovir	ACYCLOVIR	Proficient Rx LP	33630a35-346e-43b6-9286-89e28ac0094a	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075382 application number: ANDA075382

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	e0f17e6f-63c7-4828-8585-91fc582df30b	102
197313	acyclovir 800 MG Oral Tablet	SCD	e0f17e6f-63c7-4828-8585-91fc582df30b	102
197313	acycycloguanosine 800 MG Oral Tablet	SY	e0f17e6f-63c7-4828-8585-91fc582df30b	102
197313	acyclovir 800 MG Oral Tablet	PSN	f3cbd634-77c8-3306-bdbd-a4598b20603e	22
197313	acyclovir 800 MG Oral Tablet	SCD	f3cbd634-77c8-3306-bdbd-a4598b20603e	22
197313	acycycloguanosine 800 MG Oral Tablet	SY	f3cbd634-77c8-3306-bdbd-a4598b20603e	22
197311	acyclovir 400 MG Oral Tablet	PSN	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197313	acyclovir 800 MG Oral Tablet	PSN	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197311	acyclovir 400 MG Oral Tablet	SCD	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197313	acyclovir 800 MG Oral Tablet	SCD	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197311	acycycloguanosine 400 MG Oral Tablet	SY	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197313	acycycloguanosine 800 MG Oral Tablet	SY	6e203fa9-ee97-1e08-8d6a-fb57cfa13e19	16
197311	acyclovir 400 MG Oral Tablet	PSN	a68e610a-841c-4b69-9233-673d060561e8	9
197313	acyclovir 800 MG Oral Tablet	PSN	a68e610a-841c-4b69-9233-673d060561e8	9
197311	acyclovir 400 MG Oral Tablet	SCD	a68e610a-841c-4b69-9233-673d060561e8	9
197313	acyclovir 800 MG Oral Tablet	SCD	a68e610a-841c-4b69-9233-673d060561e8	9
197311	acycycloguanosine 400 MG Oral Tablet	SY	a68e610a-841c-4b69-9233-673d060561e8	9
197313	acycycloguanosine 800 MG Oral Tablet	SY	a68e610a-841c-4b69-9233-673d060561e8	9
197311	acyclovir 400 MG Oral Tablet	PSN	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
197313	acyclovir 800 MG Oral Tablet	PSN	97a10bb6-52c0-495d-e053-2995a90a60a4	8
197313	acyclovir 800 MG Oral Tablet	PSN	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
313564	valACYclovir 1 GM Oral Tablet	PSN	97a10bb6-52c0-495d-e053-2995a90a60a4	8
197311	acyclovir 400 MG Oral Tablet	SCD	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
197313	acyclovir 800 MG Oral Tablet	SCD	97a10bb6-52c0-495d-e053-2995a90a60a4	8
197313	acyclovir 800 MG Oral Tablet	SCD	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
313564	valacyclovir 1000 MG Oral Tablet	SCD	97a10bb6-52c0-495d-e053-2995a90a60a4	8
197311	acycycloguanosine 400 MG Oral Tablet	SY	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
197313	acycycloguanosine 800 MG Oral Tablet	SY	785d68bc-0bbf-b69d-e053-2991aa0ac0d5	8
197313	acycycloguanosine 800 MG Oral Tablet	SY	97a10bb6-52c0-495d-e053-2995a90a60a4	8
313564	valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet	SY	97a10bb6-52c0-495d-e053-2995a90a60a4	8
313564	valacyclovir 1 GM Oral Tablet	SY	97a10bb6-52c0-495d-e053-2995a90a60a4	8
197311	acyclovir 400 MG Oral Tablet	PSN	33630a35-346e-43b6-9286-89e28ac0094a	5
197313	acyclovir 800 MG Oral Tablet	PSN	33630a35-346e-43b6-9286-89e28ac0094a	5
197311	acyclovir 400 MG Oral Tablet	SCD	33630a35-346e-43b6-9286-89e28ac0094a	5
197313	acyclovir 800 MG Oral Tablet	SCD	33630a35-346e-43b6-9286-89e28ac0094a	5
197311	acycycloguanosine 400 MG Oral Tablet	SY	33630a35-346e-43b6-9286-89e28ac0094a	5
197313	acycycloguanosine 800 MG Oral Tablet	SY	33630a35-346e-43b6-9286-89e28ac0094a	5
197311	acyclovir 400 MG Oral Tablet	PSN	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	PSN	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	PSN	de4858e6-b601-4da2-8af1-2481c2bc6ef6	3
197311	acyclovir 400 MG Oral Tablet	SCD	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	SCD	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acyclovir 800 MG Oral Tablet	SCD	de4858e6-b601-4da2-8af1-2481c2bc6ef6	3
197311	acycycloguanosine 400 MG Oral Tablet	SY	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	bf1e7864-07c5-4c2c-a075-fad00612ee2a	3
197313	acycycloguanosine 800 MG Oral Tablet	SY	de4858e6-b601-4da2-8af1-2481c2bc6ef6	3
197313	acyclovir 800 MG Oral Tablet	PSN	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2
197313	acyclovir 800 MG Oral Tablet	SCD	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2
197313	acycycloguanosine 800 MG Oral Tablet	SY	c2d9940a-ce88-5fd0-e053-2a95a90a4bc8	2
197313	acyclovir 800 MG Oral Tablet	PSN	4eb22254-48d3-4f9d-9db4-0882c05e5763	1
197313	acyclovir 800 MG Oral Tablet	SCD	4eb22254-48d3-4f9d-9db4-0882c05e5763	1
197313	acycycloguanosine 800 MG Oral Tablet	SY	4eb22254-48d3-4f9d-9db4-0882c05e5763	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61442-113-01	61442011301	24 BOTTLE, PLASTIC in 1 BOX (61442-113-01) / 100 TABLET in 1 BOTTLE, PLASTIC	2020-01-24	0000-00-00	No	No	Current
61442-113-05	61442011305	12 BOTTLE, PLASTIC in 1 BOX (61442-113-05) / 500 TABLET in 1 BOTTLE, PLASTIC	2020-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Tablets USP	NuCare Pharmaceuticals,Inc.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	2
Acyclovir Tablets USP	AvPAK	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	16
Acyclovir Tablets USP	Preferred Pharmaceuticals Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir Tablets USP	Bryant Ranch Prepack	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	22
Acyclovir Tablets USP	Bryant Ranch Prepack	2024-09-06	HUMAN PRESCRIPTION DRUG LABEL	102
Acyclovir Tablets USP	Golden State Medical Supply, Inc.	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	8
Acyclovir Tablets USP	Carlsbad Technology, Inc.	2024-08-26	HUMAN PRESCRIPTION DRUG LABEL	9
Acyclovir Tablets USP	REMEDYREPACK INC.	2023-10-02	HUMAN PRESCRIPTION DRUG LABEL	2
VALACYCLOVIR HYDROCHLORIDE	DIRECT RX	2023-06-29	HUMAN PRESCRIPTION DRUG LABEL	8
Acyclovir Tablets USP	A-S Medication Solutions	2023-06-15	HUMAN PRESCRIPTION DRUG LABEL	15
Acyclovir Tablets USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Acyclovir Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-05	HUMAN PRESCRIPTION DRUG LABEL	2
Acyclovir Tablets USP	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
Acyclovir Tablets USP	Bryant Ranch Prepack	2022-04-14	HUMAN PRESCRIPTION DRUG LABEL	23
Acyclovir Tablets USP	Quality Care Products, LLC	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	2
Acyclovir Tablets USP	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
Acyclovir Tablets USP	Aidarex Pharmaceuticals LLC	2018-05-21	HUMAN PRESCRIPTION DRUG LABEL	1
Acyclovir Tablets USP	A-S Medication Solutions	2018-01-23	HUMAN PRESCRIPTION DRUG LABEL	6
acyclovir - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-06-04	HUMAN PRESCRIPTION DRUG LABEL	1
Acyclovir	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-04-04	HUMAN PRESCRIPTION DRUG LABEL	3