acyclovir

Product NDC: 68788-8247
11-digit product format: 687888247
Labeler code: 68788
Product ID: 68788-8247_39622b79-6854-4436-a668-25d11c8f3198
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc
Application: ANDA205974
Marketing category: ANDA
Marketing start: 2022-08-19
Substance: ACYCLOVIR
Active strength: 50 mg/g
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 42.

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
A205974-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB		2019-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205974-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205974-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-03-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205974-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205974-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205974-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205974-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205974-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205974-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205974-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205974-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205974-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205974-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205974-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205974-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205974-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205974-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205974-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205974-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205974-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205974-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205974-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205974-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205974-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205974-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205974-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205974-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205974-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205974-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205974-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205974-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205974-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205974-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205974-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205974-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205974-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205974-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205974-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205974-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205974-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205974-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205974-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205974-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	50 mg/g

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
197312	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
c11c1136-7421-48ff-86d2-39507e80a04c	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
68788-8247-1	acyclovir	1 in 1 CARTON	OINTMENT	1		5
68788-8247-1	acyclovir	15 g in 1 TUBE	OINTMENT	15		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8247-1	GM - Gram	68788-8247	a47041dd-0f45-47e7-a6d0-306e802a01d3	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8247	ACYCLOVIR OINTMENT [PREFERRED PHARMACEUTICALS INC]	4	Current NDC, Legacy NDC, 2 package rows	20241229_c11c1136-7421-48ff-86d2-39507e80a04c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	Sportpharm LLC	c561bf77-5b26-4f23-9d49-9d964b48f772	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974
acyclovir	ACYCLOVIR	Preferred Pharmaceuticals Inc	c11c1136-7421-48ff-86d2-39507e80a04c	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974 ndc (product): 68788-8247
acyclovir	ACYCLOVIR	Zydus Lifesciences Limited	fdf6b492-a76e-4cea-89a1-a5b19c7938ff	2024-08-14		Exact identifier application applno (ANDA): 205974 application number: ANDA205974
acyclovir	ACYCLOVIR	Viona Pharmaceuticals Inc	12df1991-fb1c-45df-acf3-706b1e8ecfc3	2022-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205974 application number: ANDA205974

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
197312	acyclovir 5 % Topical Ointment	PSN	c11c1136-7421-48ff-86d2-39507e80a04c	5
197312	acyclovir 0.05 MG/MG Topical Ointment	SCD	c11c1136-7421-48ff-86d2-39507e80a04c	5
197312	acyclovir 5 % Topical Ointment	SY	c11c1136-7421-48ff-86d2-39507e80a04c	5
197312	acyclovir 50 MG per 1 GM Topical Ointment	SY	c11c1136-7421-48ff-86d2-39507e80a04c	5
197312	acycycloguanosine 0.05 MG/MG Topical Ointment	SY	c11c1136-7421-48ff-86d2-39507e80a04c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8247-1	68788824701	1 TUBE in 1 CARTON (68788-8247-1) / 15 g in 1 TUBE	1 tube	2022-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Ointment USP, 5%	Preferred Pharmaceuticals Inc	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	5