Acyclovir

Product NDC
81288-019
Requested package NDC
81288-019-01
11-digit product format
812880019
Labeler code
81288
Product ID
81288-019_a266fef4-6cf6-4e3e-9df2-a531b7ca7102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA210401
Marketing category
ANDA
Marketing start
2022-07-29
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
800 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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage81288-01981288-019-01IInactivated by FDA2026-08-07

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A210401-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2018-03-07
A210401-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2018-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210401-001AB
A210401-002AB

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 UTC2026-02A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210401-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210401-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210401-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210401-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210401-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210401-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210401-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210401-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210401-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210401-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210401-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210401-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210401-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210401-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210401-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210401-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210401-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210401-002AB1782e0a99824c…

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
81288-019-012025-01-30C16284748780-12cef2736-59ec-d83d-e063-dadaa90ab31fACYCLOVIR TABLETS USP, 800 mg
81288-019-022025-01-30C16284748780-12cef2736-59ec-d83d-e063-dadaa90ab31fACYCLOVIR TABLETS USP, 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81288-019-01Acyclovir100 in 1 BOTTLETABLET1001
81288-019-02Acyclovir500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81288-019ACYCLOVIR TABLET [EMC PHARMA, LLC]1Legacy NDC, 2 package rows20220729_f74ab549-7636-45c1-bd5f-e79a1492ee2d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRRedpharm Drug53cbca4d-3ddc-b11e-e063-6394a90a04fa2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRWestminster Pharmaceuticals, LLCf352a641-988e-4878-8016-2b69cd6ee5482026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRBryant Ranch Prepack69e5455e-d0be-4c2b-b9ab-458b5480ed572026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutions2e6a3667-af06-40de-80c0-8c4346e0671f2026-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc75334fc5-d236-401a-875c-f4f9c7749c1a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.67e7b340-0635-2595-e053-2a91aa0ad2662025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.677edfd5-2d04-b932-e053-2a91aa0a26b02025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRRedpharm Drug37453bcd-e34e-5902-e063-6294a90a02452025-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRChartwell RX, LLC8cd22728-34b4-4e55-8339-580138fe46d82025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LPd0908b3c-f5dd-4113-9080-bb01abe13c9c2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRBryant Ranch Prepack8d171c3d-de39-4f82-bacb-3e8d71b165402025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutionsb96e44ca-aa54-4a64-89f4-fb5a5932ceae2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutionsc0c29e0f-b6e2-49df-88d1-95b7b625d3562024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutions6ea3e3f6-132d-4b15-ac58-336de05201a72024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LP290af212-7332-4914-9ef0-65760478fb322024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LP97ed8713-4b3e-48a9-92c0-0a98ecf0485c2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNf74ab549-7636-45c1-bd5f-e79a1492ee2d1
197313acyclovir 800 MG Oral TabletSCDf74ab549-7636-45c1-bd5f-e79a1492ee2d1
197313acycycloguanosine 800 MG Oral TabletSYf74ab549-7636-45c1-bd5f-e79a1492ee2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81288-019-0181288001901100 TABLET in 1 BOTTLE (81288-019-01) 100 tablet2022-07-290000-00-00NoNoCurrent