NDC 59368-449 - Cetirizine HCl

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
59368-449
Package NDCs from labels
59368-449-03, 59368-449-04, 59368-449-01, 59368-449-02
Manufacturer
Sixarp, LLC
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine HCl - Sixarp, LLCSixarp, LLC2026-05-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59368-449-01Cetirizine HCl80 in 1 BOTTLE, PLASTICCAPSULE801
59368-449-02Cetirizine HCl1 in 1 CARTONCAPSULE11
59368-449-03Cetirizine HCl40 in 1 BOTTLE, PLASTICCAPSULE401
59368-449-04Cetirizine HCl1 in 1 CARTONCAPSULE11

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 45 of 45 · 882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc760dd0e4-280a-4d95-8938-cecaa7ec75f22013-06-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDr.Reddy's Laboratories Limitedde152651-bfcd-856a-8329-a2ac93a376bc2011-09-30WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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