ALLEROFF

Product NDC
16853-1261
11-digit product format
168531261
Labeler code
16853
Product ID
16853-1261_110b051e-8123-4443-b9c3-9e3181a528b2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Corporacion Infarmasa
Application
NDA022155
Marketing category
NDA
Marketing start
2010-01-15
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 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
16853-1261-12019-10-21C16284748780-1956f9ecf-d0dd-621f-e053-dbdaa90a74adDrug Facts
16853-1261-22019-10-21C16284748780-1956f9ecf-d0dd-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16853-1261-1ALLEROFF1 in 1 CARTONSYRUP14
16853-1261-2ALLEROFF2 in 1 PACKAGE, COMBINATIONSYRUP24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16853-1261ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]4Legacy NDC, 2 package rows20100607_b82fbeb9-021a-484b-9896-5a5b945c5827.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020019alleroff 5 MG in 5 mL Oral SolutionPSNb82fbeb9-021a-484b-9896-5a5b945c58274
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNb82fbeb9-021a-484b-9896-5a5b945c58274
1020019cetirizine hydrochloride 1 MG/ML Oral Solution [Alleroff]SBDb82fbeb9-021a-484b-9896-5a5b945c58274
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDb82fbeb9-021a-484b-9896-5a5b945c58274
1020019Alleroff (cetirizine dihydrochloride 1 MG/ML) Oral SolutionSYb82fbeb9-021a-484b-9896-5a5b945c58274
1020019Alleroff 1 MG/ML Oral SolutionSYb82fbeb9-021a-484b-9896-5a5b945c58274
1020019Alleroff 5 MG per 5 ML Oral SolutionSYb82fbeb9-021a-484b-9896-5a5b945c58274
1014673cetirizine HCl 1 MG/ML Oral SyrupSYb82fbeb9-021a-484b-9896-5a5b945c58274
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYb82fbeb9-021a-484b-9896-5a5b945c58274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16853-1261-1168531261011 in 1 CARTONHistorical
16853-1261-2168531261022 in 1 PACKAGE, COMBINATIONHistorical