cetirizine hydrochloride

Product NDC
50090-4358
11-digit product format
500904358
Labeler code
50090
Product ID
50090-4358_221c8407-8af7-416c-ada5-7ebecaa85a0c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078336
Marketing category
ANDA
Marketing start
2007-12-27
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-4358-0cetirizine hydrochloride30 in 1 BOTTLETABLET301
50090-4358-1cetirizine hydrochloride30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4358CETIRIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20190626_e6f4e9ad-65fc-422c-98b8-22745aefc5f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe6f4e9ad-65fc-422c-98b8-22745aefc5f51
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe6f4e9ad-65fc-422c-98b8-22745aefc5f51
1014678cetirizine HCl 10 MG Oral TabletSYe6f4e9ad-65fc-422c-98b8-22745aefc5f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4358-05009043580030 TABLET in 1 BOTTLE (50090-4358-0) 30 tablet2019-06-140000-00-00NoNoCurrent
50090-4358-15009043580130 TABLET in 1 BOTTLE (50090-4358-1) 30 tablet2019-06-140000-00-00NoNoCurrent