Valacyclovir Hydrochloride

Product NDC
71335-1341
11-digit product format
713351341
Labeler code
71335
Product ID
71335-1341_97d0395b-b5bd-45d9-bd2b-a1791a787a5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078518
Marketing category
ANDA
Marketing start
2010-05-24
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
2026-12-31
Current FDA listing
Yes

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
A078518-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24
A078518-002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078518-001AB
A078518-002AB

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 UTC2026-02A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078518-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A078518-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24782e0a99824c…

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 UTC2026-02A078518-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078518-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078518-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078518-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078518-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078518-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078518-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078518-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078518-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078518-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078518-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078518-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078518-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078518-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078518-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078518-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078518-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078518-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078518-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078518-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078518-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078518-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078518-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078518-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078518-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078518-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078518-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078518-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078518-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078518-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078518-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078518-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078518-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078518-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078518-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078518-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078518-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078518-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078518-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078518-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G447S0T1VCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313565Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c28c069f-3b51-4474-aa38-1aed6b7b8678Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1341-0Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
71335-1341-1Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155
71335-1341-2Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
71335-1341-3Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED45
71335-1341-4Valacyclovir Hydrochloride7 in 1 BOTTLETABLET, FILM COATED75
71335-1341-5Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
71335-1341-6Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
71335-1341-7Valacyclovir Hydrochloride8 in 1 BOTTLETABLET, FILM COATED85
71335-1341-8Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905
71335-1341-9Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1341VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20230331_c28c069f-3b51-4474-aa38-1aed6b7b8678.zip

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.1ecd2332-4c60-46c1-a175-774926ffc6c62026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIRNorthwind Health Company, LLC1b53c6bb-0e8c-f49a-e063-6294a90a0f5a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIRNorthwind Health Company, LLC5036e5f8-e659-6010-e063-6294a90af9472026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepackc28c069f-3b51-4474-aa38-1aed6b7b86782026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
ndc (product): 71335-1341
Valacyclovir HydrochlorideVALACYCLOVIRSafecor Health LLC021ab9d0-7b75-40cf-afde-446942d643882026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIRMylan Pharmaceuticals Inc.56bf715d-8280-4557-9f98-9693932199e52026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIRRedpharm Drug301edb6c-9ce0-f9fa-e063-6294a90a29092025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIRPreferred Pharmaceuticals Inc.9eff97fa-095c-483c-a4eb-e46e5fef77852025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEMylan Institutional Inc.2f0ecd75-e4b4-4493-b7a4-1666fc555c702025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078518
application number: ANDA078518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNc28c069f-3b51-4474-aa38-1aed6b7b86785
313565valacyclovir 500 MG Oral TabletSCDc28c069f-3b51-4474-aa38-1aed6b7b86785
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc28c069f-3b51-4474-aa38-1aed6b7b86785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1341-07133513410060 TABLET, FILM COATED in 1 BOTTLE (71335-1341-0) 2019-11-080000-00-00NoNoCurrent
71335-1341-17133513410115 TABLET, FILM COATED in 1 BOTTLE (71335-1341-1) 2021-04-230000-00-00NoNoCurrent
71335-1341-27133513410210 TABLET, FILM COATED in 1 BOTTLE (71335-1341-2) 2019-09-130000-00-00NoNoCurrent
71335-1341-3713351341034 TABLET, FILM COATED in 1 BOTTLE (71335-1341-3) 2021-12-280000-00-00NoNoCurrent
71335-1341-4713351341047 TABLET, FILM COATED in 1 BOTTLE (71335-1341-4) 2020-09-040000-00-00NoNoCurrent
71335-1341-57133513410520 TABLET, FILM COATED in 1 BOTTLE (71335-1341-5) 2020-05-220000-00-00NoNoCurrent
71335-1341-67133513410630 TABLET, FILM COATED in 1 BOTTLE (71335-1341-6) 2019-09-120000-00-00NoNoCurrent
71335-1341-7713351341078 TABLET, FILM COATED in 1 BOTTLE (71335-1341-7) 2020-01-160000-00-00NoNoCurrent
71335-1341-87133513410890 TABLET, FILM COATED in 1 BOTTLE (71335-1341-8) 2021-12-280000-00-00NoNoCurrent
71335-1341-97133513410914 TABLET, FILM COATED in 1 BOTTLE (71335-1341-9) 2020-02-040000-00-00NoNoCurrent