Valacyclovir Hydrochloride

Product NDC
52959-303
11-digit product format
529590303
Labeler code
52959
Product ID
52959-303_dbcf8a7d-54ef-41ef-b7d6-7b0ad073a7b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077135
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/1
Pharmacologic classes
Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-303IInactivated by FDA2026-08-11
excluded packagepackage52959-30352959-303-21IInactivated by FDA2026-08-11

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 · 44 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 packagepackage52959-303-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-303-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-303-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-303-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-303-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-303-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-303-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-303-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-303-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-303-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-303-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-303-21557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-303-218af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-303-21834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-303-211332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-303-21fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-303-2186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-303-21bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-303-218dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-303-21e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52959-303-219bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52959-303-21110d247fa046…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
A077135-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24
A077135-002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24

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 UTC2026-02A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077135-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A077135-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077135-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077135-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077135-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077135-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077135-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077135-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077135-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077135-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077135-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077135-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077135-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077135-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077135-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077135-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077135-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077135-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077135-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077135-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077135-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077135-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077135-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077135-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077135-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077135-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077135-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077135-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077135-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077135-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077135-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A077135-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077135-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A077135-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077135-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077135-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077135-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077135-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077135-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077135-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077135-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077135-002AB13f0d92c62455…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-303-21Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-303-21EA - Each52959-303b6135417-7e7e-4db1-88f7-44cc2fd2737a12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-303VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5Legacy NDC, 1 package rows20120420_bcfc31a1-b604-4cd1-a9e0-681e60d4cd2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNbcfc31a1-b604-4cd1-a9e0-681e60d4cd2e5
313564valacyclovir 1000 MG Oral TabletSCDbcfc31a1-b604-4cd1-a9e0-681e60d4cd2e5
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYbcfc31a1-b604-4cd1-a9e0-681e60d4cd2e5
313564valacyclovir 1 GM Oral TabletSYbcfc31a1-b604-4cd1-a9e0-681e60d4cd2e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-303-215295903032121 in 1 BOTTLEHistorical