FDA.reportPublic FDA data

NDC 50386-1011-2 - Rovera

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50386-1011
Requested NDC
50386-1011-2
Package NDCs from labels
50386-1011-1, 50386-1011-2, 50386-1011-3
Manufacturer
Vicar Operating, Inc.
Effective date
2020-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rovera ® (carprofen) Chewable TabletsVicar Operating, Inc.2020-08-11PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50386-1011-1Rovera30 in 1 BOTTLETABLET302
50386-1011-1Rovera12 in 1 CASETABLET122
50386-1011-2Rovera12 in 1 CASETABLET122
50386-1011-2Rovera60 in 1 BOTTLETABLET602
50386-1011-3Rovera180 in 1 BOTTLETABLET1802
50386-1011-3Rovera12 in 1 CASETABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50386-1011ROVERA (CARPROFEN) TABLET [VICAR OPERATING, INC.]26 package rows20200813_4ae3727a-7bb8-45ed-bab2-3d094dce91d5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carprofenACTIVE INGREDIENTFFL0D546HOROVERA (CARPROFEN) TABLET [VICAR OPERATING, INC.]1
carprofenACTIVE MOIETYFFL0D546HOROVERA (CARPROFEN) TABLET [VICAR OPERATING, INC.]1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.