FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
0781-5209
11-digit product format
007815209
Labeler code
0781
Product ID
0781-5209_7ad950ff-aaff-4da0-b1ae-403d86fb06a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA077478
Marketing category
ANDA
Marketing start
2010-05-24
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
No
Listing certified through
2022-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5209-31EA - Each0781-520951595c09-ceb2-4d62-b858-1673e5e9125712012-07-24
0781-5209-92EA - Each0781-52090b543768-3b28-4f06-b186-de3f136e808412012-07-24

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5209-0100781520901100 TABLET in 1 BOTTLE (0781-5209-01) 100 tablet2010-05-240000-00-00NoNoCurrent
0781-5209-0500781520905500 TABLET in 1 BOTTLE (0781-5209-05) 500 tablet2010-05-240000-00-00NoNoCurrent
0781-5209-1300781520913100 TABLET in 1 BOX, UNIT-DOSE (0781-5209-13) 100 tablet2010-05-240000-00-00NoNoCurrent
0781-5209-270078152092721 TABLET in 1 BOTTLE (0781-5209-27) 21 tablet2010-05-240000-00-00NoNoCurrent
0781-5209-310078152093130 TABLET in 1 BOTTLE (0781-5209-31) 30 tablet2010-05-240000-00-00NoNoCurrent
0781-5209-920078152099290 TABLET in 1 BOTTLE (0781-5209-92) 90 tablet2010-05-240000-00-00NoNoCurrent