Valacyclovir

Product NDC
0093-7258
11-digit product format
000937258
Labeler code
0093
Product ID
0093-7258_33aeb435-683b-4406-8a60-88384b210bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077655
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
2019-06-30
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
0000-00-00
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 productproduct0093-7258DDiscontinued by firm2026-08-17
excluded packagepackage0093-72580093-7258-56DDiscontinued by firm2026-08-17
excluded packagepackage0093-72580093-7258-98DDiscontinued by firm2026-08-17

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 · 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 packagepackage0093-7258-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7258-98d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7258-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7258-98f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7258-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7258-982ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7258-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7258-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7258-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7258-98cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7258-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7258-98cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7258-56302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7258-98302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7258-56ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7258-98ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7258-560efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7258-980efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7258-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7258-98ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7258-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7258-98367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7258-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7258-98557ba5c1ecfa…9c80585c8c6e…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7258-56EA - Each0093-7258b930a6af-3e06-4e15-a13f-362709fde62412012-07-24
0093-7258-98EA - Each0093-7258d6dcd91e-97fe-48b8-9ae8-f6c2b23161c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
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 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