Cetirizine Hydrochloride

Product NDC
50090-1089
11-digit product format
500901089
Labeler code
50090
Product ID
50090-1089_16b3ec1f-f35c-4ae6-9b43-774adaee3071
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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
50090-1089-0Cetirizine Hydrochloride14 in 1 BOTTLETABLET148
50090-1089-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET308
50090-1089-2Cetirizine Hydrochloride100 in 1 BOTTLETABLET1008
50090-1089-3Cetirizine Hydrochloride90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1089-0EA - Each50090-10892984f35c-c9d5-41a0-bfe0-06b8fd156cbd12018-11-06
50090-1089-1EA - Each50090-108980d471a3-dd67-44fc-908b-74f0901fcacf12018-11-06
50090-1089-2EA - Each50090-1089d6b90d99-2022-4573-8472-5ad56e54a65712018-11-06
50090-1089-3EA - Each50090-108924b54ee6-67c9-4a7b-b146-1033b3e3310412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1089CETIRIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 4 package rows20200121_b7a580d5-edfc-41b5-9713-ea18eeb9252e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNb7a580d5-edfc-41b5-9713-ea18eeb9252e8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb7a580d5-edfc-41b5-9713-ea18eeb9252e8
1014678cetirizine HCl 10 MG Oral TabletSYb7a580d5-edfc-41b5-9713-ea18eeb9252e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1089-05009010890014 in 1 BOTTLEHistorical
50090-1089-15009010890130 TABLET in 1 BOTTLE (50090-1089-1) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1089-250090108902100 TABLET in 1 BOTTLE (50090-1089-2) 100 tablet2014-11-280000-00-00NoNoCurrent
50090-1089-35009010890390 TABLET in 1 BOTTLE (50090-1089-3) 90 tablet2014-11-280000-00-00NoNoCurrent