Acyclovir

Product NDC
67296-1089
Requested package NDC
67296-1089-5
11-digit product format
672961089
Labeler code
67296
Product ID
67296-1089_d60fd320-eb37-4489-e053-2995a90a8432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
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 packagepackage67296-108967296-1089-5IInactivated 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 1 · 16 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 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A203834-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2013-10-29
A203834-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALABRS2013-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203834-001AB
A203834-002AB

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 UTC2026-02A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203834-002ACYCLOVIR800MGTABLET / ORALAB2013-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29782e0a99824c…

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 UTC2026-02A203834-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203834-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203834-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203834-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203834-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203834-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203834-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203834-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203834-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203834-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203834-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203834-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203834-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203834-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203834-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203834-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203834-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203834-002AB1782e0a99824c…

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
67296-1089-22024-01-30C16284748780-11030e365-669d-111a-e063-dadaa90a10e24e7965f2-09ba-6f9a-e054-00144ff8d46c
67296-1089-52024-01-30C16284748780-11030e365-669d-111a-e063-dadaa90a10e24e7965f2-09ba-6f9a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1089-2Acyclovir20 in 1 BOTTLETABLET203
67296-1089-5Acyclovir15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1089ACYCLOVIR TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20220121_4e7965f2-09ba-6f9a-e054-00144ff8d46c.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRREMEDYREPACK INC.6d0e492e-5359-49e8-812d-8c8e2e5d42f82026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRREMEDYREPACK INC.736679be-469e-4bdb-8e15-b10751c3dd602026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRREMEDYREPACK INC.38547daa-7d2f-4a7b-84d3-6e164984f9582026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRSt. Mary's Medical Park Pharmacy1493e22d-455d-b613-e063-6294a90afede2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRBryant Ranch Prepackdbdb7903-0991-413d-b1ad-ab0f1ae2d8f42026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.db0a0ce5-dc39-4bd3-8b97-21ce9c9999f02026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRBryant Ranch Prepack0e78d5e8-ae2d-4e84-b8c2-6765b1299c122026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.e8a0f9f8-294f-4dd6-bd55-10a6253f1aa82026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRMajor Pharmaceuticals46150f19-ce5d-42a0-80a7-f96fda2b98792026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPreferred Pharmaceuticals, Inc.b6d69697-12bb-4548-a6c3-2463cbf54f8f2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRCamber Pharmaceuticals, Inc.0910335b-6796-459f-b97e-d7ef5439a0602026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNorthwind Health Company, LLC5dcfd21c-43f0-469c-be70-a4e74e6ccf882026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNorthwind Health Company, LLCf6f56143-ea74-af87-e053-6394a90ae3462026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRAdvanced Rx Pharmacy of Tennessee, LLCf4c5779d-e4bf-4f2b-e053-2995a90a91872024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.638803d2-a172-486d-e053-2991aa0ab0742024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals, Inc.5176c7f9-9076-4797-e054-00144ff8d46c2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.83e82707-85b6-2fea-e053-2991aa0a99ef2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRA-S Medication Solutionse4f91376-9e18-41a4-aa5e-adcea0c625d92023-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPharmPak, Inc.d824fc07-9f03-4cb2-9bf8-ff7cc29552552022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPharmPak, Inc.8fb01f23-e2bd-6850-e053-2995a90a7cc52022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN4e7965f2-09ba-6f9a-e054-00144ff8d46c3
197311acyclovir 400 MG Oral TabletSCD4e7965f2-09ba-6f9a-e054-00144ff8d46c3
197311acycycloguanosine 400 MG Oral TabletSY4e7965f2-09ba-6f9a-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1089-56729610890515 TABLET in 1 BOTTLE (67296-1089-5) 15 tablet2013-11-290000-00-00NoNoCurrent