FDA.reportPublic FDA data

Valacyclovir

Product NDC
63304-905
11-digit product format
633040905
Labeler code
63304
Product ID
63304-905_744b60c8-568b-4726-881c-68709c30f28a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
ANDA076588
Marketing category
ANDA
Marketing start
2020-12-19
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
Valacyclovir
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-905-032020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-12-19C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-01-31C16284748780-19d75b9d0-769f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-905-03Valacyclovir10 in 1 BOTTLETABLET, FILM COATED1018
63304-905-05Valacyclovir500 in 1 BOTTLETABLET, FILM COATED50018
63304-905-11Valacyclovir1 in 1 BLISTER PACKTABLET, FILM COATED118
63304-905-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED3018
63304-905-77Valacyclovir100 in 1 CARTONTABLET, FILM COATED10018
63304-905-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-905-30EA - Each63304-905ea493b51-c70d-484d-94b6-aa3736a4cf2712012-07-24
63304-905-90EA - Each63304-905dfbae9e0-a985-4745-b57b-0676259de03712021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-905VALACYCLOVIR TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 6 package rows20231130_26634bf1-c6d8-4d48-9a4e-845c47df07f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN26634bf1-c6d8-4d48-9a4e-845c47df07f818
313565valACYclovir 500 MG Oral TabletPSN26634bf1-c6d8-4d48-9a4e-845c47df07f818
313564valacyclovir 1000 MG Oral TabletSCD26634bf1-c6d8-4d48-9a4e-845c47df07f818
313565valacyclovir 500 MG Oral TabletSCD26634bf1-c6d8-4d48-9a4e-845c47df07f818
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY26634bf1-c6d8-4d48-9a4e-845c47df07f818
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY26634bf1-c6d8-4d48-9a4e-845c47df07f818
313564valacyclovir 1 GM Oral TabletSY26634bf1-c6d8-4d48-9a4e-845c47df07f818
313564valACYclovir 1 GM Oral TabletPSNe3b4757b-d97b-6714-e053-2995a90a64eb4
313565valACYclovir 500 MG Oral TabletPSNe3b4757b-d97b-6714-e053-2995a90a64eb4
313564valacyclovir 1000 MG Oral TabletSCDe3b4757b-d97b-6714-e053-2995a90a64eb4
313565valacyclovir 500 MG Oral TabletSCDe3b4757b-d97b-6714-e053-2995a90a64eb4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe3b4757b-d97b-6714-e053-2995a90a64eb4
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYe3b4757b-d97b-6714-e053-2995a90a64eb4
313564valacyclovir 1 GM Oral TabletSYe3b4757b-d97b-6714-e053-2995a90a64eb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-905-036330409050310 TABLET, FILM COATED in 1 BOTTLE (63304-905-03) 2020-12-190000-00-00NoNoCurrent
63304-905-0563304090505500 TABLET, FILM COATED in 1 BOTTLE (63304-905-05) 2020-12-190000-00-00NoNoCurrent
63304-905-11633040905111 in 1 BLISTER PACKHistorical
63304-905-306330409053030 TABLET, FILM COATED in 1 BOTTLE (63304-905-30) 2020-12-190000-00-00NoNoCurrent
63304-905-7763304090577100 BLISTER PACK in 1 CARTON (63304-905-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-905-11) 100 blister pack2020-12-190000-00-00NoNoCurrent
63304-905-906330409059090 TABLET, FILM COATED in 1 BOTTLE (63304-905-90) 2020-12-190000-00-00NoNoCurrent