ACYCLOVIR

Product NDC
67296-0375
11-digit product format
672960375
Labeler code
67296
Product ID
67296-0375_75712ad2-36fe-4a9d-a722-970e4e594bec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA074596
Marketing category
ANDA
Marketing start
2009-04-01
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
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-0375IInactivated by FDA2026-08-07
excluded packagepackage67296-037567296-0375-1IInactivated by FDA2026-08-07
excluded packagepackage67296-037567296-0375-2IInactivated by FDA2026-08-07
excluded packagepackage67296-037567296-0375-3IInactivated 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 2 · 88 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 packagepackage67296-0375-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0375-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0375-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0375-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0375-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0375-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0375-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0375-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0375-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0375-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0375-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0375-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0375-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0375-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0375-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0375-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0375-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0375-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0375-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0375-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0375-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0375-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0375-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0375-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0375-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0375-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0375-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0375-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0375-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0375-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0375-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0375-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0375-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0375-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0375-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0375-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0375-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0375-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0375-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0375-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0375-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0375-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0375-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0375-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0375-11332a3947898…d4bfe170f9cd…

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
A074596-001ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22
A074596-002ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22

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 UTC2026-02A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074596-001ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1997-04-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A074596-002ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1997-04-22782e0a99824c…

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
67296-0375-12020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets
67296-0375-22020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets
67296-0375-32020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0375-1ACYCLOVIR20 in 1 BOTTLETABLET205
67296-0375-2ACYCLOVIR30 in 1 BOTTLETABLET305
67296-0375-3ACYCLOVIR70 in 1 BOTTLETABLET705

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [REDPHARM DRUG INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [REDPHARM DRUG INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0375ACYCLOVIR TABLET [REDPHARM DRUG INC.]5Legacy NDC, 3 package rows20110808_ffa99978-6b66-49ab-9bd2-8ef6f6846cd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acyclovir 400 MG Oral TabletSCDffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acycycloguanosine 400 MG Oral TabletSYffa99978-6b66-49ab-9bd2-8ef6f6846cd75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0375-16729603750120 in 1 BOTTLEHistorical
67296-0375-26729603750230 in 1 BOTTLEHistorical
67296-0375-36729603750370 in 1 BOTTLEHistorical