FDA.reportPublic FDA data

NDC 49427-346 - 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
49427-346
Package NDCs from labels
49427-346-57, 49427-346-44
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
49427-346-44PROIN ER90 in 1 BOTTLETABLET, EXTENDED RELEASE902
49427-346-57PROIN ER30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49427-346PROIN ER (PHENYLPROPANOLAMINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PEGASUS LABORATORIES, INC.]22 package rows20231221_54cec27b-4119-4ea1-b4fd-59cb5e002b64.zip