Cetirizine Hydrochloride

Product NDC
67668-162
11-digit product format
676680162
Labeler code
67668
Product ID
67668-162_ba27b932-bae3-41d2-bfe4-017c4f036670
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unique Pharmaceutical Laboratories
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
E
Listing certified through
2018-12-31
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
67668-162-00Cetirizine Hydrochloride100 in 1 BOTTLETABLET1002
67668-162-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET302
67668-162-45Cetirizine Hydrochloride45 in 1 BOTTLETABLET452

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67668-162CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]2Legacy NDC, 3 package rows20091222_6a37e1da-7949-4704-adb4-e9d018ac5301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN6a37e1da-7949-4704-adb4-e9d018ac53012
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6a37e1da-7949-4704-adb4-e9d018ac53012
1014678cetirizine HCl 10 MG Oral TabletSY6a37e1da-7949-4704-adb4-e9d018ac53012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67668-162-0067668016200100 in 1 BOTTLEHistorical
67668-162-306766801623030 in 1 BOTTLEHistorical
67668-162-456766801624545 in 1 BOTTLEHistorical