Acyclovir

Product NDC
53002-0271
Requested package NDC
53002-0271-0
11-digit product format
530020271
Labeler code
53002
Product ID
53002-0271_f794a1d0-e49b-4f3c-8fd2-27e130d6dff0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
2021-12-31
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 packagepackage53002-027153002-0271-0IInactivated 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 · 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
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

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 UTC2026-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30782e0a99824c…

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 UTC2026-02A075382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002AB1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0271-0Acyclovir50 in 1 BOTTLETABLET503
53002-0271-1Acyclovir10 in 1 BOTTLETABLET103
53002-0271-2Acyclovir15 in 1 BOTTLETABLET153
53002-0271-3Acyclovir20 in 1 BOTTLETABLET203
53002-0271-4Acyclovir30 in 1 BOTTLETABLET303
53002-0271-5Acyclovir35 in 1 BOTTLETABLET353
53002-0271-6Acyclovir40 in 1 BOTTLETABLET403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0271ACYCLOVIR TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 7 package rows20230609_de4858e6-b601-4da2-8af1-2481c2bc6ef6.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNde4858e6-b601-4da2-8af1-2481c2bc6ef63
197313acyclovir 800 MG Oral TabletSCDde4858e6-b601-4da2-8af1-2481c2bc6ef63
197313acycycloguanosine 800 MG Oral TabletSYde4858e6-b601-4da2-8af1-2481c2bc6ef63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0271-05300202710050 TABLET in 1 BOTTLE (53002-0271-0) 50 tablet2020-01-010000-00-00NoNoCurrent