Valacyclovir Hydrochloride

Product NDC
53808-0635
11-digit product format
538080635
Labeler code
53808
Product ID
53808-0635_2d482302-2476-4395-bcc2-53404748c889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077655
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 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
2019-12-31
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 productproduct53808-0635IInactivated by FDA2026-08-17
excluded packagepackage53808-063553808-0635-1IInactivated by FDA2026-08-17

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 · 42 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 packagepackage53808-0635-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0635-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0635-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0635-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0635-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0635-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0635-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0635-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0635-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0635-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0635-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0635-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0635-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0635-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0635-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0635-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0635-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0635-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0635-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0635-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0635-19bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077655-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24
A077655-002VALACYCLOVIR 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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077655-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2010-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077655-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORAL2010-05-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077655-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077655-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077655-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077655-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077655-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077655-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077655-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077655-002AB1ea99ee380514…

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
53808-0635-1Valacyclovir Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0635VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_bdd38bb5-ff30-4392-a151-5234b9342304.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNbdd38bb5-ff30-4392-a151-5234b93423041
313565valacyclovir 500 MG Oral TabletSCDbdd38bb5-ff30-4392-a151-5234b93423041
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYbdd38bb5-ff30-4392-a151-5234b93423041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0635-15380806350130 in 1 BLISTER PACKHistorical