FDA.reportPublic FDA data

VALTREX

Product NDC
0173-0565
11-digit product format
001730565
Labeler code
0173
Product ID
0173-0565_753fde77-5750-4c98-a167-daa531f3d872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA020487
Marketing category
NDA
Marketing start
2002-08-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC

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
0173-0565-04VALTREX30 in 1 BOTTLETABLET, FILM COATED3031
0173-0565-10VALTREX90 in 1 BOTTLETABLET, FILM COATED9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0565-04EA - Each0173-056508339ee3-4b43-4f12-8598-327a91d9d25812012-07-24
0173-0565-10EA - Each0173-0565f1ea8976-0476-4a50-a205-82751d0fe5ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POVIDONESINACTIVE INGREDIENTFZ989GH94EVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0565VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]29Current NDC, Legacy NDC, 2 package rows20240625_f8e0d8f8-cb73-4206-a484-88f5c4fbd719.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313565valACYclovir 500 MG Oral TabletPSNf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
212448VALTREX 1 GM Oral TabletPSNf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
108780VALTREX 500 MG Oral TabletPSNf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBDf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
108780valacyclovir 500 MG Oral Tablet [Valtrex]SBDf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313564valacyclovir 1000 MG Oral TabletSCDf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313565valacyclovir 500 MG Oral TabletSCDf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313564valacyclovir 1 GM Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
108780Valtrex (as valacyclovir hydrochloride) 500 MG Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
212448Valtrex 1 GM Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
212448Valtrex 1000 MG Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
108780Valtrex 500 MG Oral TabletSYf8e0d8f8-cb73-4206-a484-88f5c4fbd71931
313564valACYclovir 1 GM Oral TabletPSN56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
212448VALTREX 1 GM Oral TabletPSN56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBD56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
313564valacyclovir 1000 MG Oral TabletSCD56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
313564valacyclovir 1 GM Oral TabletSY56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSY56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
212448Valtrex 1 GM Oral TabletSY56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
212448Valtrex 1000 MG Oral TabletSY56a62c21-bead-4f3b-a24e-c3fd0b4a732f14
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
313564valACYclovir 1 GM Oral TabletPSNb4450539-78ec-4e8a-8cfc-56dcde7984a02
313565valACYclovir 500 MG Oral TabletPSNb4450539-78ec-4e8a-8cfc-56dcde7984a02
212448VALTREX 1 GM Oral TabletPSNb4450539-78ec-4e8a-8cfc-56dcde7984a02
108780VALTREX 500 MG Oral TabletPSNb4450539-78ec-4e8a-8cfc-56dcde7984a02
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBDb4450539-78ec-4e8a-8cfc-56dcde7984a02
108780valacyclovir 500 MG Oral Tablet [Valtrex]SBDb4450539-78ec-4e8a-8cfc-56dcde7984a02
313564valacyclovir 1000 MG Oral TabletSCDb4450539-78ec-4e8a-8cfc-56dcde7984a02
313565valacyclovir 500 MG Oral TabletSCDb4450539-78ec-4e8a-8cfc-56dcde7984a02
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
313564valacyclovir 1 GM Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
108780Valtrex (as valacyclovir hydrochloride) 500 MG Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
212448Valtrex 1 GM Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
212448Valtrex 1000 MG Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
108780Valtrex 500 MG Oral TabletSYb4450539-78ec-4e8a-8cfc-56dcde7984a02
313564valACYclovir 1 GM Oral TabletPSN1f338cd7-3520-337b-e063-6294a90aa45d1
212448VALTREX 1 GM Oral TabletPSN1f338cd7-3520-337b-e063-6294a90aa45d1
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBD1f338cd7-3520-337b-e063-6294a90aa45d1
313564valacyclovir 1000 MG Oral TabletSCD1f338cd7-3520-337b-e063-6294a90aa45d1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1f338cd7-3520-337b-e063-6294a90aa45d1
313564valacyclovir 1 GM Oral TabletSY1f338cd7-3520-337b-e063-6294a90aa45d1
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSY1f338cd7-3520-337b-e063-6294a90aa45d1
212448Valtrex 1 GM Oral TabletSY1f338cd7-3520-337b-e063-6294a90aa45d1
212448Valtrex 1000 MG Oral TabletSY1f338cd7-3520-337b-e063-6294a90aa45d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0173-0565-040017305650430 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04) 2002-08-120000-00-00NoNoCurrent
0173-0565-100017305651090 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10) 2002-08-120000-00-00NoNoCurrent