FDA.reportPublic FDA data

VALACYCLOVIR

Product NDC
51660-904
11-digit product format
516600904
Labeler code
51660
Product ID
51660-904_623aa8f4-d84d-4dae-9fcb-51e2b288d52a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA076588
Marketing category
ANDA
Marketing start
2009-11-25
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-904-032020-01-31C16284748780-19d75b9d0-facf-f424-e053-dadaa90a57ce51f93a1c-90d0-4cbc-90f7-6f1415efd673
51660-904-052020-01-31C16284748780-19d75b9d0-facf-f424-e053-dadaa90a57ce51f93a1c-90d0-4cbc-90f7-6f1415efd673
51660-904-302020-01-31C16284748780-19d75b9d0-facf-f424-e053-dadaa90a57ce51f93a1c-90d0-4cbc-90f7-6f1415efd673
51660-904-772020-01-31C16284748780-19d75b9d0-facf-f424-e053-dadaa90a57ce51f93a1c-90d0-4cbc-90f7-6f1415efd673
51660-904-902020-01-31C16284748780-19d75b9d0-facf-f424-e053-dadaa90a57ce51f93a1c-90d0-4cbc-90f7-6f1415efd673

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-904VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [OHM LABORATORIES INC.]1Legacy NDC20140228_51f93a1c-90d0-4cbc-90f7-6f1415efd673.zip