FDA.reportPublic FDA data

Cetirizine hydrochloride

Product NDC
23155-929
11-digit product format
231550929
Labeler code
23155
Product ID
23155-929_ef266d70-f451-4938-b720-2103625cd384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Application
ANDA078876
Marketing category
ANDA
Marketing start
2025-03-01
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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 HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-929-51Cetirizine hydrochloride120 mL in 1 BOTTLESOLUTION1201
23155-929-52Cetirizine hydrochloride473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-929-52ML - Milliliter23155-92920ce0e9d-bef5-4af9-985a-5dfe6c80755012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-929CETIRIZINE HYDROCHLORIDE SOLUTION [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.]1Current NDC, 2 package rows20250302_a9b21d71-106e-4bd5-aaab-9254c8a44e0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa9b21d71-106e-4bd5-aaab-9254c8a44e0d1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa9b21d71-106e-4bd5-aaab-9254c8a44e0d1
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa9b21d71-106e-4bd5-aaab-9254c8a44e0d1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa9b21d71-106e-4bd5-aaab-9254c8a44e0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-929-5123155092951120 mL in 1 BOTTLE (23155-929-51) 120 ml2025-03-01NoNoCurrent
23155-929-5223155092952473 mL in 1 BOTTLE (23155-929-52) 473 ml2025-03-01NoNoCurrent