CETIRIZINE HYDROCHLORIDE

Product NDC
72162-2073
11-digit product format
721622073
Labeler code
72162
Product ID
72162-2073_9028db40-d89a-477b-a528-7f1c2ed5de64
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212266
Marketing category
ANDA
Marketing start
2022-10-15
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2073-2CETIRIZINE HYDROCHLORIDE1 in 1 CARTONSOLUTION1104
72162-2073-2CETIRIZINE HYDROCHLORIDE118 mL in 1 BOTTLESOLUTION118104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2073-2ML - Milliliter72162-2073db026de8-7a6d-4472-be0b-f46f06bcbc7b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2073CETIRIZINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20250224_9c11dd22-cb17-4179-8c54-1d515bf662d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9c11dd22-cb17-4179-8c54-1d515bf662d2104
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9c11dd22-cb17-4179-8c54-1d515bf662d2104
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9c11dd22-cb17-4179-8c54-1d515bf662d2104
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9c11dd22-cb17-4179-8c54-1d515bf662d2104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2073-2721622073021 BOTTLE in 1 CARTON (72162-2073-2) / 118 mL in 1 BOTTLE1 bottle2022-10-15NoNoHistorical