Childrens Cetirizine Hydrochloride

Product NDC
71205-705
11-digit product format
712050705
Labeler code
71205
Product ID
71205-705_582db483-394e-4c00-8522-4041a11696e4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Cetirizine Hydrochloride
Brand name suffix
Sugar Free Grape
Listing expiration
2026-12-31

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
71205-705-72Childrens Cetirizine HydrochlorideSugar Free Grape120 mL in 1 BOTTLESOLUTION1201
71205-705-72Childrens Cetirizine HydrochlorideSugar Free Grape1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-705CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20221015_582db483-394e-4c00-8522-4041a11696e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine HCl 1 MG/ML Oral SyrupSY582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY582db483-394e-4c00-8522-4041a11696e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-705-72712050705721 BOTTLE in 1 CARTON (71205-705-72) / 120 mL in 1 BOTTLE1 bottle2022-10-130000-00-00NoNoCurrent