FDA.reportPublic FDA data

childrens cetirizine hydrochloride

Product NDC
0904-6765
11-digit product format
009046765
Labeler code
0904
Product ID
0904-6765_5f4ad745-20b6-4ed5-81aa-448c658d57c2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204226
Marketing category
ANDA
Marketing start
2018-08-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
childrens cetirizine hydrochloride
Listing expiration
2027-12-31

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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6765-20childrens cetirizine hydrochloride118 mL in 1 BOTTLESOLUTION1184
0904-6765-20childrens cetirizine hydrochloride1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6765-20ML - Milliliter0904-6765384cd178-ca8b-4538-8460-fa0b2cddbe4912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6765CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) SOLUTION [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250428_db297aa4-4384-48f2-b2bd-c842efc8a844.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9e168299-5ba1-451a-8c85-3fbe34c36cb05
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9e168299-5ba1-451a-8c85-3fbe34c36cb05
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9e168299-5ba1-451a-8c85-3fbe34c36cb05
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9e168299-5ba1-451a-8c85-3fbe34c36cb05
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNdb297aa4-4384-48f2-b2bd-c842efc8a8444
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDdb297aa4-4384-48f2-b2bd-c842efc8a8444
1014673cetirizine HCl 1 MG/ML Oral SyrupSYdb297aa4-4384-48f2-b2bd-c842efc8a8444
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYdb297aa4-4384-48f2-b2bd-c842efc8a8444
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNcb47e536-8eed-4a32-b9c2-e8535fb938862
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDcb47e536-8eed-4a32-b9c2-e8535fb938862
1014673cetirizine HCl 1 MG/ML Oral SyrupSYcb47e536-8eed-4a32-b9c2-e8535fb938862
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYcb47e536-8eed-4a32-b9c2-e8535fb938862
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e1
1014673cetirizine HCl 1 MG/ML Oral SyrupSY8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6765-20009046765201 BOTTLE in 1 CARTON (0904-6765-20) / 118 mL in 1 BOTTLE1 bottle2018-08-220000-00-00NoNoCurrent