acyclovir

Product NDC: 68788-4142
Requested package NDC: 68788-4142-1
11-digit product format: 687884142
Labeler code: 68788
Product ID: 68788-4142_59007780-d736-4195-a204-7f85a709ed46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: OINTMENT
Route: TOPICAL
Labeler: c
Application: ANDA209971
Marketing category: ANDA
Marketing start: 2026-08-12
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 43.

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
A209971-001	ACYCLOVIR	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB		2019-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209971-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209971-001	ACYCLOVIR	5%	OINTMENT / TOPICAL	AB	2019-01-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209971-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209971-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209971-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209971-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209971-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209971-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209971-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209971-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209971-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209971-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209971-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209971-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209971-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209971-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209971-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209971-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209971-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209971-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209971-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209971-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209971-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209971-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209971-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209971-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209971-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209971-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209971-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209971-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209971-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209971-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209971-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209971-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209971-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209971-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209971-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209971-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209971-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209971-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209971-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209971-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
59007780-d736-4195-a204-7f85a709ed46	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acyclovir	ACYCLOVIR	c	59007780-d736-4195-a204-7f85a709ed46	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209971 application number: ANDA209971 ndc (package): 68788-4142-1 ndc (product): 68788-4142 ndc11 (package): 68788414201
acyclovir	ACYCLOVIR	Torrent Pharmaceuticals Limited	1c510390-fb00-4271-967d-0883a9d5e1fd	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209971 application number: ANDA209971

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4142-1	68788414201	15 g in 1 TUBE (68788-4142-1)	15 g	2026-08-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR OINTMENT USP (acyclovir) 5%	c \| Preferred Pharmaceuticals Inc.	2026-08-12	HUMAN PRESCRIPTION DRUG LABEL	1