Cetirizine Hydrochloride (Allergy)

Product NDC
0363-9602
11-digit product format
003639602
Labeler code
0363
Product ID
0363-9602_7f752fde-e10a-4cbc-84bb-cd42849484c7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2021-07-05
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
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
0363-9602-09Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET304
0363-9602-09Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9602CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [WALGREEN CO.]4Current NDC, Legacy NDC, 2 package rows20230608_c0165b0e-d5e9-a028-e053-2a95a90ab431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc0165b0e-d5e9-a028-e053-2a95a90ab4314
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc0165b0e-d5e9-a028-e053-2a95a90ab4314
1014678cetirizine HCl 10 MG Oral TabletSYc0165b0e-d5e9-a028-e053-2a95a90ab4314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9602-09003639602091 BOTTLE in 1 CARTON (0363-9602-09) / 30 TABLET in 1 BOTTLE1 bottle2021-07-050000-00-00NoNoCurrent