FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
0378-4276
11-digit product format
003784276
Labeler code
0378
Product ID
0378-4276_7de6158d-06ad-4500-a485-dafc151c16ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078518
Marketing category
ANDA
Marketing start
2010-05-24
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
Valacyclovir Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564, 313565

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
0378-4276-77Valacyclovir Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
0378-4276-93Valacyclovir Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4276-05EA - Each0378-42762a4cffee-ee75-48c4-8174-71c7741cb4fc12012-07-24
0378-4276-77EA - Each0378-4276f2d9457c-df32-4615-937a-cb05ba319bd512012-07-24
0378-4276-93EA - Each0378-4276ec164c54-b5df-4745-8112-ab66a7da191112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4276VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20240123_56bf715d-8280-4557-9f98-9693932199e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN56bf715d-8280-4557-9f98-9693932199e519
313565valACYclovir 500 MG Oral TabletPSN56bf715d-8280-4557-9f98-9693932199e519
313564valacyclovir 1000 MG Oral TabletSCD56bf715d-8280-4557-9f98-9693932199e519
313565valacyclovir 500 MG Oral TabletSCD56bf715d-8280-4557-9f98-9693932199e519
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY56bf715d-8280-4557-9f98-9693932199e519
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY56bf715d-8280-4557-9f98-9693932199e519
313564valacyclovir 1 GM Oral TabletSY56bf715d-8280-4557-9f98-9693932199e519
313564valACYclovir 1 GM Oral TabletPSN1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir 1000 MG Oral TabletSCD1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir 1 GM Oral TabletSY1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valACYclovir 1 GM Oral TabletPSN5036e5f8-e659-6010-e063-6294a90af9471
313564valacyclovir 1000 MG Oral TabletSCD5036e5f8-e659-6010-e063-6294a90af9471
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY5036e5f8-e659-6010-e063-6294a90af9471
313564valacyclovir 1 GM Oral TabletSY5036e5f8-e659-6010-e063-6294a90af9471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4276-770037842767790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4276-77) 2010-05-240000-00-00NoNoCurrent
0378-4276-930037842769330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4276-93) 2010-05-240000-00-00NoNoCurrent