acyclovir

Product NDC
60429-310
11-digit product format
604290310
Labeler code
60429
Product ID
60429-310_b715cb41-67a7-a41f-e053-2995a90af576
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077309
Marketing category
ANDA
Marketing start
2013-05-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-310DDiscontinued by firm2026-08-10
excluded packagepackage60429-31060429-310-01DDiscontinued by firm2026-08-10
excluded packagepackage60429-31060429-310-05DDiscontinued by firm2026-08-10

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 · 36 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 packagepackage60429-310-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60429-310-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60429-310-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60429-310-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60429-310-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60429-310-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60429-310-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60429-310-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60429-310-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60429-310-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60429-310-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60429-310-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60429-310-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60429-310-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60429-310-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60429-310-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60429-310-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60429-310-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60429-310-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60429-310-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60429-310-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60429-310-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60429-310-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60429-310-05557ba5c1ecfa…9c80585c8c6e…

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
A077309-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2005-09-29
A077309-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2005-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077309-001AB
A077309-002AB

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 UTC2026-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29782e0a99824c…

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 UTC2026-02A077309-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002AB1782e0a99824c…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-310-01EA - Each60429-310cbb67325-7c48-410b-a31b-114a023ce16612013-06-04
60429-310-05EA - Each60429-310cec64f0d-3184-4fd8-bd64-d90ffc2b69fa12013-06-04

DailyMed Socrata Ingredients#

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRREMEDYREPACK INC.499c6a98-0614-4ded-8526-909942bae8a42026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepackdb35fce0-d7a3-4589-ba60-d78cdb1119cb2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRApotex Corp.7fdeb609-24c4-5024-52c3-6a32bc7f3fcc2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepacka7fd298b-3914-4316-8484-2d3ae188221a2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.ada4004a-c10a-6190-e053-2a95a90a5e672024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.b2ae0432-bd2a-1480-e053-2a95a90a6fc82024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.968800dc-9456-a45f-e053-2995a90aa15e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepackbf1b4142-c5f3-4147-8224-bf63445666942024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRProficient Rx LP4c5a75fa-73db-4f48-895f-de1635d33f492021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRAsclemed USA, Inc.e186fdc9-b60e-4280-8d60-36cae9f2838f2020-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRProficient Rx LP51052f0e-1a07-405a-a962-981ce9439e022020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNeb863c4f-4e39-4d97-8b7e-30a76fe2119d1
197313acyclovir 800 MG Oral TabletSCDeb863c4f-4e39-4d97-8b7e-30a76fe2119d1
197313acycycloguanosine 800 MG Oral TabletSYeb863c4f-4e39-4d97-8b7e-30a76fe2119d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-310-0160429031001100 TABLET in 1 BOTTLE (60429-310-01) 100 tablet2013-05-310000-00-00NoNoCurrent