Acyclovir

Product NDC: 0472-0082
11-digit product format: 004720082
Labeler code: 0472
Product ID: 0472-0082_6f58843b-1a91-42b4-b03c-7cad93c931d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: SUSPENSION
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA074738
Marketing category: ANDA
Marketing start: 2002-09-03
Substance: ACYCLOVIR
Active strength: 200 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074738-001	ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB		1997-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074738-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074738-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	1997-04-28	`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	A074738-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074738-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074738-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074738-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074738-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074738-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074738-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074738-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074738-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074738-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074738-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074738-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074738-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074738-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074738-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074738-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074738-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074738-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074738-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074738-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074738-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074738-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074738-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074738-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074738-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074738-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074738-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074738-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074738-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074738-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074738-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074738-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074738-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074738-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074738-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074738-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074738-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074738-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074738-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074738-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	200 mg/5mL

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
307730	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
a4c1305c-f18c-4fb0-83d8-2822341f2dfa	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
0472-0082-16	Acyclovir	473 mL in 1 BOTTLE	SUSPENSION	473		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0082-16	ML - Milliliter	0472-0082	eade4ea7-b374-4a92-be34-c18472a48b89	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACYCLOVIR SUSPENSION [ACTAVIS MID ATLANTIC LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0082	ACYCLOVIR SUSPENSION [ACTAVIS PHARMA, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250424_a4c1305c-f18c-4fb0-83d8-2822341f2dfa.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	ATLANTIC BIOLOGICALS CORP.	da5a809c-6ddc-4609-9a34-ccb3d2d43976	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074738 application number: ANDA074738
Acyclovir	ACYCLOVIR	Actavis Pharma, Inc.	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074738 application number: ANDA074738 ndc (product): 0472-0082
Acyclovir	ACYCLOVIR	ATLANTIC BIOLOGICALS CORP.	4032ce02-e2b3-d426-e063-6294a90ab6c9	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074738 application number: ANDA074738

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
307730	acyclovir 200 MG in 5 mL Oral Suspension	PSN	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	7
307730	acyclovir 40 MG/ML Oral Suspension	SCD	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	7
307730	acyclovir 200 MG per 5 ML Oral Suspension	SY	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	7
307730	acycycloguanosine 40 MG/ML Oral Suspension	SY	a4c1305c-f18c-4fb0-83d8-2822341f2dfa	7
307730	acyclovir 200 MG in 5 mL Oral Suspension	PSN	da5a809c-6ddc-4609-9a34-ccb3d2d43976	5
307730	acyclovir 40 MG/ML Oral Suspension	SCD	da5a809c-6ddc-4609-9a34-ccb3d2d43976	5
307730	acyclovir 200 MG per 5 ML Oral Suspension	SY	da5a809c-6ddc-4609-9a34-ccb3d2d43976	5
307730	acycycloguanosine 40 MG/ML Oral Suspension	SY	da5a809c-6ddc-4609-9a34-ccb3d2d43976	5
307730	acyclovir 200 MG in 5 mL Oral Suspension	PSN	4032ce02-e2b3-d426-e063-6294a90ab6c9	1
307730	acyclovir 40 MG/ML Oral Suspension	SCD	4032ce02-e2b3-d426-e063-6294a90ab6c9	1
307730	acyclovir 200 MG per 5 ML Oral Suspension	SY	4032ce02-e2b3-d426-e063-6294a90ab6c9	1
307730	acycycloguanosine 40 MG/ML Oral Suspension	SY	4032ce02-e2b3-d426-e063-6294a90ab6c9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0082-16	00472008216	473 mL in 1 BOTTLE (0472-0082-16)	473 ml	2002-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR ORAL SUSPENSION, USP Rx Only	ATLANTIC BIOLOGICALS CORP.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	6
Acyclovir Oral Suspension, USP Rx only	Actavis Pharma, Inc.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	7
ACYCLOVIR ORAL SUSPENSION, USP Rx Only	ATLANTIC BIOLOGICALS CORP.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	1