Cetirizine Hydrochloride

Product NDC
67668-161
11-digit product format
676680161
Labeler code
67668
Product ID
67668-161_89050554-8e16-41ce-88a5-30718b7f6f9c
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
5 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
67668-161-00Cetirizine Hydrochloride100 in 1 BOTTLETABLET1002
67668-161-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET302
67668-161-45Cetirizine Hydrochloride45 in 1 BOTTLETABLET452

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67668-161CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]2Legacy NDC, 3 package rows20091222_139536a1-b021-4ef3-902f-b618da5aaa44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014676cetirizine HCl 5 MG Oral TabletPSN139536a1-b021-4ef3-902f-b618da5aaa442
1014676cetirizine hydrochloride 5 MG Oral TabletSCD139536a1-b021-4ef3-902f-b618da5aaa442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67668-161-0067668016100100 in 1 BOTTLEHistorical
67668-161-306766801613030 in 1 BOTTLEHistorical
67668-161-456766801614545 in 1 BOTTLEHistorical