FDA.reportPublic FDA data

NDC 49427-345-57 - PROIN ER

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
49427-345
Requested NDC
49427-345-57
Package NDCs from labels
49427-345-57, 49427-345-44
Manufacturer
Pegasus Laboratories, Inc.
Effective date
2023-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROIN ER - Pegasus Laboratories, Inc.Pegasus Laboratories, Inc.2023-12-20PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49427-345-44PROIN ER90 in 1 BOTTLETABLET, EXTENDED RELEASE902
49427-345-57PROIN ER30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49427-345PROIN ER (PHENYLPROPANOLAMINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PEGASUS LABORATORIES, INC.]22 package rows20231221_c26843de-74ba-4a51-a18c-2d3bc0bcb07a.zip

Reported adverse events (FAERS/openFDA)#

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