FDA.reportPublic FDA data

APTRIZINE

Product NDC
46084-012
11-digit product format
460840012
Labeler code
46084
Product ID
46084-012_113f7b27-dc67-473f-80ed-275c08320439
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
A P J Laboratories Limited
Application
ANDA019835
Marketing category
ANDA
Marketing start
2013-02-21
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
46084-012-112019-11-27C16284748780-19855d018-df94-cd31-e053-dbdaa90ab51a22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-122019-11-27C16284748780-19855d018-df94-cd31-e053-dbdaa90ab51a22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-132019-11-27C16284748780-19855d018-df94-cd31-e053-dbdaa90ab51a22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-142019-11-27C16284748780-19855d018-df94-cd31-e053-dbdaa90ab51a22e5db90-4cee-47af-9e3e-3636d99974ba
46084-012-152019-11-27C16284748780-19855d018-df94-cd31-e053-dbdaa90ab51a22e5db90-4cee-47af-9e3e-3636d99974ba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-012-11APTRIZINE24-HOUR ALL DAY ALLERGY15 in 1 BLISTER PACKTABLET152
46084-012-12APTRIZINE24-HOUR ALL DAY ALLERGY30 in 1 BLISTER PACKTABLET302
46084-012-13APTRIZINE24-HOUR ALL DAY ALLERGY45 in 1 BLISTER PACKTABLET452
46084-012-14APTRIZINE24-HOUR ALL DAY ALLERGY60 in 1 BLISTER PACKTABLET602
46084-012-15APTRIZINE24-HOUR ALL DAY ALLERGY120 in 1 BLISTER PACKTABLET1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
CETIRIZINEACTIVE MOIETYYO7261ME24APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAPTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-012APTRIZINE 24-HOUR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]2Legacy NDC, 5 package rows20130221_22e5db90-4cee-47af-9e3e-3636d99974ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN22e5db90-4cee-47af-9e3e-3636d99974ba2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD22e5db90-4cee-47af-9e3e-3636d99974ba2
1014678cetirizine HCl 10 MG Oral TabletSY22e5db90-4cee-47af-9e3e-3636d99974ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46084-012-114608400121115 in 1 BLISTER PACKHistorical
46084-012-124608400121230 in 1 BLISTER PACKHistorical
46084-012-134608400121345 in 1 BLISTER PACKHistorical
46084-012-144608400121460 in 1 BLISTER PACKHistorical
46084-012-1546084001215120 in 1 BLISTER PACKHistorical