ZOVIRAX

Product NDC: 40076-991
11-digit product format: 400760991
Labeler code: 40076
Product ID: 40076-991_69406605-d942-44d4-baa9-97537048f21e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Prestium Pharma, Inc.
Application: NDA018828
Marketing category: NDA
Marketing start: 2014-02-07
Marketing end: 2019-12-31
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: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	40076-991		D	Discontinued by firm		2026-11-06
excluded package	package	40076-991	40076-991-55	D	Discontinued by firm		2026-11-06

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40076-991-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40076-991-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40076-991-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40076-991-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40076-991-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40076-991-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40076-991-55	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40076-991-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40076-991-55	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40076-991-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40076-991-55	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40076-991-55	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018828-001	ZOVIRAX	ACYCLOVIR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL		RLD	1985-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL		RLD	1985-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL	AB	RLD	1985-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1985-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1985-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1985-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1985-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL		RLD	1985-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL		RLD	1985-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL	AB	RLD	1985-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018828-001	ZOVIRAX	200MG	CAPSULE / ORAL	AB	RLD	1985-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018828-001	ZOVIRAX	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1985-01-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018828-001	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	N018828-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018828-001	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
40076-991-55	EA - Each	40076-991	813c4625-a8b6-452a-b9f9-01ab76b3e4c7	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOVIRAX (ACYCLOVIR) CAPSULE ZOVIRAX (ACYCLOVIR) TABLET ZOVIRAX (ACYCLOVIR) SUSPENSION [PRESTIUM PHARMA, INC.]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZOVIRAX ® (acyclovir) Capsules ZOVIRAX ® (acyclovir) Tablets ZOVIRAX ® (acyclovir) Suspension	Prestium Pharma, Inc.	2014-02-10	HUMAN PRESCRIPTION DRUG LABEL	5