Cetirizine Hydrochloride (Allergy)

Product NDC
11822-4228
11-digit product format
118224228
Labeler code
11822
Product ID
11822-4228_e3c8a262-ed07-4ae0-be85-be55d3459695
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RITE AID CORPORATION
Application
ANDA209107
Marketing category
ANDA
Marketing start
2022-06-24
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
Cetirizine Hydrochloride (Allergy)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

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
11822-4228-1Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE12
11822-4228-1Cetirizine Hydrochloride (Allergy)25 in 1 BOTTLECAPSULE252
11822-4228-2Cetirizine Hydrochloride (Allergy)40 in 1 BOTTLECAPSULE402
11822-4228-2Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4228CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [RITE AID CORPORATION]2Current NDC, Legacy NDC, 4 package rows20220723_de169567-5cde-5c4a-e053-2a95a90a1215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNde169567-5cde-5c4a-e053-2a95a90a12152
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDde169567-5cde-5c4a-e053-2a95a90a12152
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYde169567-5cde-5c4a-e053-2a95a90a12152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4228-1118224228011 BOTTLE in 1 CARTON (11822-4228-1) / 25 CAPSULE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
11822-4228-2118224228021 BOTTLE in 1 CARTON (11822-4228-2) / 40 CAPSULE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent