FDA.reportPublic FDA data

VALTREX

Product NDC
70518-2039
11-digit product format
705182039
Labeler code
70518
Product ID
70518-2039_499baba0-82b1-4029-e063-6294a90a0297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020487
Marketing category
NDA
Marketing start
2019-04-26
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
2027-12-31
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
Rxcui212448, 313564

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
70518-2039-02023-03-07C16284748780-1f386c64a-258b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir) tablets, for oral use Initial U.S. Approval: 1995
70518-2039-02023-01-30C16284748780-1f386c64a-258b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX. VALTREX (valacyclovir) tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2039-0VALTREX10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014
70518-2039-1VALTREX14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-2039-2VALTREX5 in 1 BOTTLE, PLASTICTABLET, FILM COATED514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2039VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 3 package rows20250523_56a62c21-bead-4f3b-a24e-c3fd0b4a732f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2039-07051820390010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-0) 2019-04-260000-00-00NoNoCurrent
70518-2039-17051820390114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-1) 2023-07-17NoNoCurrent
70518-2039-2705182039025 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-2) 2023-10-02NoNoCurrent