NDC 0091-3352-01 - KEMSTRO

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
0091-3352
Requested NDC
0091-3352-01
Package NDCs from labels
0091-3352-01
Manufacturer
Schwarz Pharma
Effective date
2006-01-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KEMSTRO - Schwarz PharmaSchwarz Pharma2006-01-04Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0091-3352-01KEMSTRO100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0091-3352KEMSTRO (BACLOFEN) TABLET, ORALLY DISINTEGRATING [SCHWARZ PHARMA]11 package rows20060921_F133FE04-1550-4FA4-9DC4-652C27936BF2.zip

DailyMed Socrata Ingredients#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0058D65D-0AFB-C56B-C935-DBEDA286B4F2F133FE04-1550-4FA4-9DC4-652C27936BF22006-01-04Warnings, Adverse reactionsExact identifier
spl id: 0058D65D-0AFB-C56B-C935-DBEDA286B4F2
spl set id: F133FE04-1550-4FA4-9DC4-652C27936BF2

Reported adverse events (FAERS/openFDA)#

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