FDA.reportPublic FDA data

NDC 42546-135 - PR Cream

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
42546-135
Package NDCs from labels
42546-135-04
Manufacturer
PruGen, Inc.
Effective date
2012-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PR Cream Nonsteroidal CreamPruGen, Inc.2012-09-04PRESCRIPTION MEDICAL DEVICE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-135-04PR Cream56.7 g in 1 TUBE56.71
42546-135-04PR Cream2 in 1 BOX21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-135PR CREAM () [PRUGEN, INC.]12 package rows20120906_5403a1f8-5432-4e47-b140-7083d65ba670.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-135-04GM - Gram42546-135388fd00b-78ff-4514-826e-e870c09cda9812013-02-19

Reported adverse events (FAERS/openFDA)#

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