Cetirizine Hydrochloride

Product NDC
33261-393
11-digit product format
332610393
Labeler code
33261
Product ID
33261-393_18da72cf-bc71-46c3-a184-f99740bf8d7d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-393-10Cetirizine Hydrochloride10 in 1 BOTTLETABLET101
33261-393-14Cetirizine Hydrochloride14 in 1 BOTTLETABLET141
33261-393-20Cetirizine Hydrochloride20 in 1 BOTTLETABLET201
33261-393-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-393CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20120922_3d3596d8-cebc-4bdf-be21-3f5a4e0446ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1
1014678cetirizine HCl 10 MG Oral TabletSY3d3596d8-cebc-4bdf-be21-3f5a4e0446ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-393-103326103931010 in 1 BOTTLEHistorical
33261-393-143326103931414 in 1 BOTTLEHistorical
33261-393-203326103932020 in 1 BOTTLEHistorical
33261-393-303326103933030 in 1 BOTTLEHistorical