Cetirizine Hydrochloride (Allergy)

Product NDC
21130-099
11-digit product format
211300099
Labeler code
21130
Product ID
21130-099_b3b261a6-e56a-458a-a5a4-92bd95f4e2fc
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA209107
Marketing category
ANDA
Marketing start
2023-11-15
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
21130-099-97Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE12
21130-099-97Cetirizine Hydrochloride (Allergy)25 in 1 BOTTLECAPSULE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-099CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [BETTER LIVING BRANDS, LLC]2Current NDC, 2 package rows20231123_f7deb8ca-4a26-aece-e053-6294a90aa685.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNf7deb8ca-4a26-aece-e053-6294a90aa6852
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDf7deb8ca-4a26-aece-e053-6294a90aa6852
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYf7deb8ca-4a26-aece-e053-6294a90aa6852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-099-97211300099971 BOTTLE in 1 CARTON (21130-099-97) / 25 CAPSULE in 1 BOTTLE1 bottle2023-11-15NoNoCurrent