Acyclovir

Product NDC: 63187-182
Requested package NDC: 63187-182-30
11-digit product format: 631870182
Labeler code: 63187
Product ID: 63187-182_347e3045-6810-4821-ab70-0ba268a4cc2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075090
Marketing category: ANDA
Marketing start: 2009-10-22
Marketing end: 0000-00-00
Substance: ACYCLOVIR
Active strength: 200 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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-182	63187-182-30	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-182	63187-182-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-182	63187-182-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A075090-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		1999-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075090-001	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	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`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	A075090-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-182-90	EA - Each	63187-182	f1bc4ee9-cdff-42ee-80c3-fb850c058948	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-182	ACYCLOVIR CAPSULE [PROFICIENT RX LP]	3	Legacy NDC	20210121_b2c19660-4f9e-48e2-9918-5954962c45ab.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Florida Pharmaceutical Products, LLC	3df7fa38-a869-45fb-98a3-81c5a2527d62	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f87c2c1e-568f-49e1-979e-fce80086fe08	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6e813b35-4ead-42d6-bc51-9d7caf1db1ef	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e8433261-07f1-448b-aaf4-631414598c08	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Quinn Pharmaceuticals	9ad711e4-003d-4b58-8177-32928bc42aa9	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Proficient Rx LP	6714cfd9-97d3-4290-b618-54594d89cf4e	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090

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	Marketing end	Sample	Exclude flag	Status
63187-182-30	63187018230	30 CAPSULE in 1 BOTTLE, PLASTIC (63187-182-30)	30 capsule	2019-01-01	0000-00-00	No	No	Current