FDA.reportPublic FDA data

ALLEROFF

Product NDC
16853-1305
11-digit product format
168531305
Labeler code
16853
Product ID
16853-1305_98661a3c-c95c-4ab1-b62f-87dde7f88296
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Corporacion Infarmasa
Application
NDA019835
Marketing category
NDA
Marketing start
2010-01-01
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
16853-1305-22019-10-21C16284748780-1956f9ecf-cea6-621f-e053-dbdaa90a74adDrug Facts
16853-1305-32019-10-21C16284748780-1956f9ecf-cea6-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16853-1305-1ALLEROFF000000000010 in 1 BLISTER PACKTABLET0000000000102
16853-1305-2ALLEROFF00000000000001 in 1 BOXTABLET000000000000012
16853-1305-3ALLEROFF0000000002 in 1 BLISTER PACKTABLET00000000022

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CetirizineACTIVE MOIETYYO7261ME24ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16853-1305ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2Legacy NDC, 3 package rows20100603_2e431020-bf57-46a7-bbfd-487b87d00ffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020025Alleroff 10 MG Oral TabletPSN2e431020-bf57-46a7-bbfd-487b87d00ffb2
1014678cetirizine HCl 10 MG Oral TabletPSN2e431020-bf57-46a7-bbfd-487b87d00ffb2
1020025cetirizine hydrochloride 10 MG Oral Tablet [Alleroff]SBD2e431020-bf57-46a7-bbfd-487b87d00ffb2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2e431020-bf57-46a7-bbfd-487b87d00ffb2
1020025Alleroff (cetirizine dihydrochloride 10 MG) Oral TabletSY2e431020-bf57-46a7-bbfd-487b87d00ffb2
1020025Alleroff 10 MG Oral TabletSY2e431020-bf57-46a7-bbfd-487b87d00ffb2
1014678cetirizine HCl 10 MG Oral TabletSY2e431020-bf57-46a7-bbfd-487b87d00ffb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16853-1305-116853130501000000000010 in 1 BLISTER PACKHistorical
16853-1305-21685313050200000000000001 in 1 BOXHistorical
16853-1305-3168531305030000000002 in 1 BLISTER PACKHistorical