Valacyclovir

Product NDC
61919-919
11-digit product format
619190919
Labeler code
61919
Product ID
61919-919_35e38d4b-d11f-43f9-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA077478
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-919-04Valacyclovir4 in 1 BOTTLECAPSULE44
61919-919-21Valacyclovir21 in 1 BOTTLECAPSULE214
61919-919-71Valacyclovir100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-919-04EA - Each61919-919f1bdefe0-b8c6-4314-b710-e058ad0663c712016-09-02
61919-919-21EA - Each61919-9196e1e8c2b-1c7b-4877-a56c-212cac01fe7212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
ACYCLOVIRACTIVE MOIETYX4HES1O11FDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIRECT RX (VALACYCLOVIR) CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-919VALACYCLOVIR CAPSULE [DIRECT RX]4Legacy NDC, 3 package rows20160923_536aaf2c-9ce6-4eb9-973d-343d01a262fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-919-04619190919044 in 1 BOTTLEHistorical
61919-919-216191909192121 in 1 BOTTLEHistorical
61919-919-7161919091971100 in 1 BOTTLEHistorical