Cetirizine Hydrochloride

Product NDC
21130-640
11-digit product format
211300640
Labeler code
21130
Product ID
21130-640_463f17c8-bcef-ecdb-e063-6294a90a3404
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SAFEWAY
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-06-30
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
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
21130-640-03Cetirizine Hydrochloride30 in 1 BOTTLETABLET306
21130-640-09Cetirizine Hydrochloride90 in 1 BOTTLETABLET906
21130-640-18Cetirizine Hydrochloride180 in 1 CARTONTABLET1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-640CETIRIZINE HYDROCHLORIDE TABLET [SAFEWAY]5Current NDC, 3 package rows20241212_ed0eecfb-85bf-63bf-e053-2995a90a0e03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNed0eecfb-85bf-63bf-e053-2995a90a0e036
1014678cetirizine hydrochloride 10 MG Oral TabletSCDed0eecfb-85bf-63bf-e053-2995a90a0e036
1014678cetirizine HCl 10 MG Oral TabletSYed0eecfb-85bf-63bf-e053-2995a90a0e036

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-640-032113006400330 TABLET in 1 BOTTLE (21130-640-03) 30 tablet2023-06-30NoNoCurrent
21130-640-092113006400990 TABLET in 1 BOTTLE (21130-640-09) 90 tablet2023-06-30NoNoCurrent
21130-640-1821130064018180 TABLET in 1 CARTON (21130-640-18) 180 tablet2023-06-30NoNoCurrent