FDA.reportPublic FDA data

Cetirizine Hydrochloride 10 mg

Product NDC
10267-3579
11-digit product format
102673579
Labeler code
10267
Product ID
10267-3579_3633ac85-4814-e6a7-e063-6294a90a375d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride 10 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacal Corp.
Application
ANDA076047
Marketing category
ANDA
Marketing start
2025-04-16
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 10 mg
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
10267-3579-1Cetirizine Hydrochloride 10 mg100 in 1 BOTTLETABLET, FILM COATED1002
10267-3579-1Cetirizine Hydrochloride 10 mg1 in 1 CARTONTABLET, FILM COATED12
10267-3579-3Cetirizine Hydrochloride 10 mg1 in 1 CARTONTABLET, FILM COATED12
10267-3579-3Cetirizine Hydrochloride 10 mg30 in 1 BOTTLETABLET, FILM COATED302
10267-3579-4Cetirizine Hydrochloride 10 mg100 in 1 BOTTLETABLET, FILM COATED1002
10267-3579-6Cetirizine Hydrochloride 10 mg365 in 1 BOTTLETABLET, FILM COATED3652
10267-3579-7Cetirizine Hydrochloride 10 mg60 in 1 BOTTLETABLET, FILM COATED602
10267-3579-7Cetirizine Hydrochloride 10 mg1 in 1 CARTONTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN84459f11-3405-4a8e-be38-333b7de2a5782
1014678cetirizine hydrochloride 10 MG Oral TabletSCD84459f11-3405-4a8e-be38-333b7de2a5782
1014678cetirizine HCl 10 MG Oral TabletSY84459f11-3405-4a8e-be38-333b7de2a5782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10267-3579-1102673579011 BOTTLE in 1 CARTON (10267-3579-1) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-12-31NoNoCurrent
10267-3579-3102673579031 BOTTLE in 1 CARTON (10267-3579-3) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-12-31NoNoCurrent
10267-3579-410267357904100 TABLET, FILM COATED in 1 BOTTLE (10267-3579-4) 2025-05-31NoNoCurrent
10267-3579-610267357906365 TABLET, FILM COATED in 1 BOTTLE (10267-3579-6) 2025-04-16NoNoCurrent
10267-3579-7102673579071 BOTTLE in 1 CARTON (10267-3579-7) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-12-31NoNoCurrent