FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
14445-152
11-digit product format
144450152
Labeler code
14445
Product ID
14445-152_c1a05a6d-3db7-446f-927b-787a062ad1ae
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA218895
Marketing category
ANDA
Marketing start
2024-10-04
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
14445-152-01CETIRIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006
14445-152-01CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-03CETIRIZINE HYDROCHLORIDE300 in 1 BOTTLETABLET, FILM COATED3006
14445-152-03CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-05CETIRIZINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5006
14445-152-05CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-30CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
14445-152-30CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-90CETIRIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED906
14445-152-90CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-152CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [INDOCO REMEDIES LIMITED ]6Current NDC, 10 package rows20241010_2942e093-5077-44d3-b080-8d945d03c55f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2942e093-5077-44d3-b080-8d945d03c55f6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2942e093-5077-44d3-b080-8d945d03c55f6
1014678cetirizine HCl 10 MG Oral TabletSY2942e093-5077-44d3-b080-8d945d03c55f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-152-01144450152011 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-04NoNoHistorical
14445-152-03144450152031 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-04NoNoHistorical
14445-152-05144450152051 BOTTLE in 1 CARTON (14445-152-05) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-04NoNoHistorical
14445-152-30144450152301 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-04NoNoHistorical
14445-152-90144450152901 BOTTLE in 1 CARTON (14445-152-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-04NoNoHistorical