Acyclovir

Product NDC
21695-009
11-digit product format
216950009
Labeler code
21695
Product ID
21695-009_a2db7131-bf31-47bf-bf61-594f919af1f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074975
Marketing category
ANDA
Marketing start
1998-10-30
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
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-009IInactivated by FDA2026-08-10
excluded packagepackage21695-00921695-009-25IInactivated by FDA2026-08-10
excluded packagepackage21695-00921695-009-30IInactivated by FDA2026-08-10

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-009-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-009-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-009-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-009-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-009-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-009-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-009-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-009-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-009-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-009-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-009-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-009-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-009-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-009-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-009-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-009-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-009-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-009-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-009-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-009-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-009-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-009-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-009-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-009-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-009-258af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-009-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-009-25834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-009-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-009-251332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-009-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-009-25fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-009-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-009-2586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-009-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-009-25bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-009-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-009-258dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-009-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-009-25e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-009-30e2bbac7714bc…27bdfed8d636…

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
A074975-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORAL1998-09-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074975-001ACYCLOVIR200MGCAPSULE / ORAL1998-09-30cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-009-252019-09-24C16284748780-1934fe258-4cce-48b1-e053-8cdaa90a720aAcyclovir
21695-009-302019-09-24C16284748780-1934fe258-4cce-48b1-e053-8cdaa90a720aAcyclovir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-009-25Acyclovir25 in 1 BOTTLECAPSULE251
21695-009-30Acyclovir30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-009-25EA - Each21695-0093ef5b1ce-857d-4da1-b149-6151ea65f70912012-07-24
21695-009-30EA - Each21695-0091dd5ebc6-20cf-421c-ba3a-648c0972e1f912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-009ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_a2db7131-bf31-47bf-bf61-594f919af1f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197310acyclovir 200 MG Oral CapsuleSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197310acycycloguanosine 200 MG Oral CapsuleSYa2db7131-bf31-47bf-bf61-594f919af1f21
197311acycycloguanosine 400 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21
197313acycycloguanosine 800 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-009-252169500092525 in 1 BOTTLEHistorical
21695-009-302169500093030 in 1 BOTTLEHistorical