FDA.reportPublic FDA data

NDC 42546-025 - HPRplus - MB HydroGel Kit

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
42546-025
Package NDCs from labels
42546-025-10, 42546-025-15
Manufacturer
PruGen, Inc.
Effective date
2013-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HPRplus - MB HydroGel KitPruGen, Inc.2013-05-13PRESCRIPTION MEDICAL DEVICE LABEL
HPRplus Emollient FoamPruGen, Inc.2012-09-06PRESCRIPTION MEDICAL DEVICE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-025-10HPRplus Emollient Foam1 in 1 BOX11
42546-025-10HPRplus Emollient Foam100 g in 1 CANISTER1001
42546-025-15HPRplus Emollient Foam1 in 1 BOX11
42546-025-15HPRplus Emollient Foam150 g in 1 CANISTER1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-025HPRPLUS - MB HYDROGEL KIT () KIT [PRUGEN, INC.]1Unmatched20130516_fa6dc9b3-2971-464f-ab3a-c2cae1243fbb.zip
42546-025HPRPLUS EMOLLIENT FOAM () [PRUGEN, INC.]14 package rows20120907_3683b565-8ef6-4120-a8bb-d12b0e2a5ead.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-025-10GM - Gram42546-02573ec323c-4919-4fa3-a74d-a331a38c6a8612013-02-19
42546-025-15GM - Gram42546-025dbf56df2-2e6b-441b-8f86-55cb1c8ac9da12013-02-19

Reported adverse events (FAERS/openFDA)#

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