Quality Choice Cetirizine Hydrochloride

Product NDC
63868-132
11-digit product format
638680132
Labeler code
63868
Product ID
63868-132_2f9f8dc0-8034-445c-b7b0-bf680a6be979
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quality Choice Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-132-14Quality Choice Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET142
63868-132-30Quality Choice Cetirizine Hydrochloride30 in 1 BOTTLETABLET302
63868-132-90Quality Choice Cetirizine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-132-14EA - Each63868-1326d775fae-dee4-4808-babd-1e77ef47c5a112013-02-13
63868-132-30EA - Each63868-13260d366b4-9c96-4f2b-8ba2-6a13acae60ac12013-02-13
63868-132-90EA - Each63868-132737e040a-7eae-40f0-b625-37f4e6832b5412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
CETIRIZINEACTIVE MOIETYYO7261ME24QUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-132QUALITY CHOICE CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, Legacy NDC, 3 package rows20180824_2e8cc4e3-8386-42de-801f-fef37f612849.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2e8cc4e3-8386-42de-801f-fef37f6128492
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2e8cc4e3-8386-42de-801f-fef37f6128492
1014678cetirizine HCl 10 MG Oral TabletSY2e8cc4e3-8386-42de-801f-fef37f6128492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-132-146386801321414 TABLET in 1 BLISTER PACK (63868-132-14) 14 tablet2007-12-270000-00-00NoNoCurrent
63868-132-306386801323030 TABLET in 1 BOTTLE (63868-132-30) 30 tablet2007-12-270000-00-00NoNoCurrent
63868-132-906386801329090 TABLET in 1 BOTTLE (63868-132-90) 90 tablet2007-12-270000-00-00NoNoCurrent