CETIRIZINE HYDROCHLORIDE

Product NDC
66116-417
11-digit product format
661160417
Labeler code
66116
Product ID
66116-417_010ea8e3-4955-4332-8cca-f45977ab56c6
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA078862
Marketing category
ANDA
Marketing start
2009-10-19
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-417-302019-11-27C16284748780-19855d018-d79c-cd31-e053-dbdaa90ab51a010ea8e3-4955-4332-8cca-f45977ab56c6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-417-30CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-417CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130823_010ea8e3-4955-4332-8cca-f45977ab56c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN010ea8e3-4955-4332-8cca-f45977ab56c61
1014678cetirizine hydrochloride 10 MG Oral TabletSCD010ea8e3-4955-4332-8cca-f45977ab56c61
1014678cetirizine HCl 10 MG Oral TabletSY010ea8e3-4955-4332-8cca-f45977ab56c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-417-306611604173030 in 1 BOTTLE, PLASTICHistorical