FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
55111-553
11-digit product format
551110553
Labeler code
55111
Product ID
55111-553_dc8ac169-4a86-0c1f-c57a-2bc68f6c2e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA079012
Marketing category
ANDA
Marketing start
2010-12-06
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 mg/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
2020-12-31
Current FDA listing
Historical FDA.report record

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
55111-553-012024-01-30C16284748780-11030e365-48f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-553-052024-01-30C16284748780-11030e365-48f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-553-302024-01-30C16284748780-11030e365-48f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-553-782024-01-30C16284748780-11030e365-48f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-553-902024-01-30C16284748780-11030e365-48f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-553-01Valacyclovir Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10011
55111-553-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011
55111-553-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
55111-553-78Valacyclovir Hydrochloride10 in 1 CARTONTABLET, FILM COATED1011
55111-553-79Valacyclovir Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1011
55111-553-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-553-05EA - Each55111-553ba5eeb69-252c-4e4e-86e8-d55073023d2d12012-07-24
55111-553-30EA - Each55111-553b8b9a0f4-feff-4ec4-8469-aa6889eb71ee12012-07-24
55111-553-90EA - Each55111-55355882307-5e66-4e79-bf99-c52f71afb89212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
valacyclovirACTIVE INGREDIENTMZ1IW7Q79DVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
valacyclovirACTIVE MOIETYMZ1IW7Q79DVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
carnauba waxINACTIVE INGREDIENTR12CBM0EIZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-553VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]11Legacy NDC, 6 package rows20190312_2d38cbdb-4e4d-4174-461d-7a3b6475e6a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313565valACYclovir 500 MG Oral TabletPSN2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313564valacyclovir 1000 MG Oral TabletSCD2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313565valacyclovir 500 MG Oral TabletSCD2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY2d38cbdb-4e4d-4174-461d-7a3b6475e6a511
313564valacyclovir 1 GM Oral TabletSY2d38cbdb-4e4d-4174-461d-7a3b6475e6a511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55111-553-0155111055301100 in 1 BOTTLEHistorical
55111-553-0555111055305500 in 1 BOTTLEHistorical
55111-553-305511105533030 in 1 BOTTLEHistorical
55111-553-785511105537810 in 1 CARTONHistorical
55111-553-795511105537910 in 1 BLISTER PACKHistorical
55111-553-905511105539090 in 1 BOTTLEHistorical