FDA.reportPublic FDA data

Acyclovir

Product NDC
66689-342
11-digit product format
666890342
Labeler code
66689
Product ID
66689-342_28968b08-f4ff-4076-bc3e-d9529976a9b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA213951
Marketing category
ANDA
Marketing start
2021-09-27
Marketing end
0000-00-00
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66689-342DDiscontinued by firm2026-08-11
excluded packagepackage66689-34266689-342-16DDiscontinued by firm2026-08-11

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct66689-342DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66689-34266689-342-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213951-001ACYCLOVIRACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-115aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2021-01-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213951-001ACYCLOVIR200MG/5MLSUSPENSION / ORAL2021-01-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213951-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213951-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213951-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213951-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213951-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213951-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A213951-001AB15aa47cf7b7d7…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213951-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213951-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213951-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213951-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213951-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213951-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213951-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213951-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213951-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-342-162024-01-30C16284748780-11030e365-516f-111a-e063-dadaa90a10e2ACYCLOVIR ORAL SUSPENSION, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-342-16ML - Milliliter66689-342171d3040-9de8-40bf-aece-87c359643fd012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-342ACYCLOVIR SUSPENSION [VISTAPHARM, LLC]10Legacy NDC20240712_47a4af6e-1111-458b-9a79-2199b78d8a80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-342-16666890342161 BOTTLE in 1 CARTON (66689-342-16) > 473 mL in 1 BOTTLE1 bottle2021-09-270000-00-00NoNoCurrent