VALTREX

Product NDC
67296-0200
11-digit product format
672960200
Labeler code
67296
Product ID
67296-0200_d5fbf428-e6ed-0abc-e053-2a95a90a694d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug
Application
NDA020487
Marketing category
NDA
Marketing start
2002-08-12
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/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
2023-12-31
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 productproduct67296-0200IInactivated by FDA2026-08-17
excluded packagepackage67296-020067296-0200-1IInactivated 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 · 30 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 packagepackage67296-0200-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0200-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0200-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0200-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0200-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0200-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0200-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0200-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0200-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0200-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0200-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0200-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0200-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0200-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0200-11332a3947898…d4bfe170f9cd…

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
N020487-001VALTREXVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALABRLD1995-06-23
N020487-002VALTREXVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALABRLD1995-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020487-001AB
N020487-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD1995-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD, RS1995-06-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020487-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020487-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020487-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020487-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020487-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020487-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020487-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020487-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020487-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020487-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020487-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020487-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020487-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020487-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020487-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020487-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020487-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020487-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020487-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020487-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020487-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020487-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020487-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020487-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020487-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020487-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020487-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020487-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020487-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020487-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020487-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020487-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020487-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020487-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020487-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020487-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020487-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020487-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020487-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020487-002AB1bb7c543d1eb4…

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
67296-0200-12024-01-30C16284748780-11030e364-fe70-111a-e063-dadaa90a10e2Valtrex 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0200-1VALTREX21 in 1 BOTTLETABLET, FILM COATED214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0200VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG]4Legacy NDC, 1 package rows20220120_b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALTREXVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.56a62c21-bead-4f3b-a24e-c3fd0b4a732f2026-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020487
application number: NDA020487
VALTREXVALACYCLOVIR HYDROCHLORIDEGlaxoSmithKline LLCf8e0d8f8-cb73-4206-a484-88f5c4fbd7192025-11-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020487
application number: NDA020487

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448VALTREX 1 GM Oral TabletPSNb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBDb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir 1000 MG Oral TabletSCDb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex 1000 MG Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0200-16729602000121 TABLET, FILM COATED in 1 BOTTLE (67296-0200-1) 2002-08-120000-00-00NoNoCurrent