Cetirizine Hydrochloride (Allergy)

Product NDC
21130-098
11-digit product format
211300098
Labeler code
21130
Product ID
21130-098_4471f8dd-d97b-4a3e-a238-cbf8cd606f11
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA090760
Marketing category
ANDA
Marketing start
2023-05-19
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
21130-098-23Cetirizine Hydrochloride (Allergy)120 in 1 BOTTLETABLET1202
21130-098-23Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET12
21130-098-39Cetirizine Hydrochloride (Allergy)365 in 1 BOTTLETABLET3652

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-098CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [BETTER LIVING BRANDS, LLC]2Current NDC, 3 package rows20230520_f7e16d96-4f23-cbca-e053-6394a90aef4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf7e16d96-4f23-cbca-e053-6394a90aef4e2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf7e16d96-4f23-cbca-e053-6394a90aef4e2
1014678cetirizine HCl 10 MG Oral TabletSYf7e16d96-4f23-cbca-e053-6394a90aef4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-098-23211300098231 BOTTLE in 1 CARTON (21130-098-23) / 120 TABLET in 1 BOTTLE1 bottle2023-05-19NoNoCurrent
21130-098-3921130009839365 TABLET in 1 BOTTLE (21130-098-39) 365 tablet2023-05-19NoNoCurrent