Cetirizine Hydrochloride

Product NDC
52183-088
11-digit product format
521830088
Labeler code
52183
Product ID
52183-088_2e79a844-0525-4788-af34-935b3dd04f9e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Blacksmith Brands Inc.
Application
ANDA090182
Marketing category
ANDA
Marketing start
2008-04-22
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52183-088-082020-01-31C16284748780-19d75b9d0-033a-f424-e053-dadaa90a57cePedia Care ® 2 Years & Older Children's

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52183-088-08Cetirizine Hydrochloride118 mL in 1 BOTTLESOLUTION1181
52183-088-08Cetirizine Hydrochloride1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52183-088CETIRIZINE HYDROCHLORIDE SOLUTION [BLACKSMITH BRANDS INC.]1Legacy NDC, 2 package rows20101217_20566348-4d98-4a09-81d4-e858fd864aad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN20566348-4d98-4a09-81d4-e858fd864aad1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD20566348-4d98-4a09-81d4-e858fd864aad1
1014673cetirizine HCl 1 MG/ML Oral SyrupSY20566348-4d98-4a09-81d4-e858fd864aad1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY20566348-4d98-4a09-81d4-e858fd864aad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52183-088-0852183008808118 mL in 1 BOTTLE118 mlHistorical