Acyclovir

Product NDC
21695-010
11-digit product format
216950010
Labeler code
21695
Product ID
21695-010_a2db7131-bf31-47bf-bf61-594f919af1f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074980
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
400 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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-010IInactivated by FDA2026-08-10
excluded packagepackage21695-01021695-010-20IInactivated by FDA2026-08-10
excluded packagepackage21695-01021695-010-25IInactivated by FDA2026-08-10
excluded packagepackage21695-01021695-010-30IInactivated by FDA2026-08-10
excluded packagepackage21695-01021695-010-60IInactivated by FDA2026-08-10
excluded packagepackage21695-01021695-010-90IInactivated 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 3 · 132 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 packagepackage21695-010-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-010-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-010-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-010-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-010-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-010-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-010-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-010-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-010-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-010-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-010-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-010-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-010-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-010-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-010-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-010-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-010-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-010-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-010-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-010-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-010-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-010-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-010-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-010-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-010-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-010-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-010-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-010-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-010-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-010-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-010-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-010-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-010-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-010-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-010-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-010-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-010-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-010-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-010-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-010-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-010-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-010-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-010-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-010-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-010-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-010-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-010-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-010-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-010-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-010-60ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074980-001ACYCLOVIRACYCLOVIR400MGTABLET / ORAL1998-09-30
A074980-002ACYCLOVIRACYCLOVIR800MGTABLET / 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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074980-001ACYCLOVIR400MGTABLET / ORAL1998-09-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A074980-002ACYCLOVIR800MGTABLET / ORAL1998-09-30782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-010-20Acyclovir20 in 1 BOTTLETABLET201
21695-010-25Acyclovir25 in 1 BOTTLETABLET251
21695-010-30Acyclovir30 in 1 BOTTLETABLET301
21695-010-60Acyclovir60 in 1 BOTTLETABLET601
21695-010-90Acyclovir90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-010-20EA - Each21695-0108f706d6c-14d0-4cd2-851b-44881f9e455912012-07-24
21695-010-25EA - Each21695-010dd24a73e-a4c5-4248-a161-2f225829302e12012-07-24
21695-010-30EA - Each21695-01030f3dfb7-e525-42fc-ae6a-34a8de61655012012-07-24
21695-010-60EA - Each21695-010ef3f3f19-1c16-4cb4-b2db-5c98e7aaa56612012-07-24
21695-010-90EA - Each21695-01002e145b3-1c39-4bbf-bbc9-be7c5ff5be2c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-010ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 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
21695-010-202169500102020 in 1 BOTTLEHistorical
21695-010-252169500102525 in 1 BOTTLEHistorical
21695-010-302169500103030 in 1 BOTTLEHistorical
21695-010-602169500106060 in 1 BOTTLEHistorical
21695-010-902169500109090 in 1 BOTTLEHistorical