FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
68788-8523
11-digit product format
687888523
Labeler code
68788
Product ID
68788-8523_883939e1-51a7-4b72-8a2b-09e8596cb799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078398
Marketing category
ANDA
Marketing start
2023-09-13
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8523-1Cetirizine Hydrochloride1 in 1 CARTONSOLUTION14
68788-8523-1Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8523CETIRIZINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250227_e874264a-becc-45d0-b934-779eab5f5085.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe874264a-becc-45d0-b934-779eab5f50854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8523-1687888523011 BOTTLE in 1 CARTON (68788-8523-1) / 120 mL in 1 BOTTLE1 bottle2023-09-13NoNoHistorical