FDA.reportPublic FDA data

Dye Free Childrens Cetirizine Hydrocholride

Product NDC
68094-004
11-digit product format
680940004
Labeler code
68094
Product ID
68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hcl
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA204226
Marketing category
ANDA
Marketing start
2016-10-26
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
Dye Free Childrens Cetirizine Hydrocholride
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-004-59Dye Free Childrens Cetirizine Hydrocholride5 mL in 1 CUP, UNIT-DOSESOLUTION53
68094-004-62Dye Free Childrens Cetirizine Hydrocholride3 in 1 CASESOLUTION33
68094-004-62Dye Free Childrens Cetirizine Hydrocholride10 in 1 TRAYSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-004-59ML - Milliliter68094-0048e34b6b0-7978-4b06-ac60-a9f2264fb5a712016-12-07
68094-004-62ML - Milliliter68094-0047d4d1ee8-9f5e-4229-9669-99813953d17012016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-004DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE (CETIRIZINE HCL) SOLUTION [PRECISION DOSE, INC.]3Current NDC, Legacy NDC, 3 package rows20250215_6a7c4dff-66c6-4d0c-af10-d908c65a43be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6a7c4dff-66c6-4d0c-af10-d908c65a43be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-004-59680940004595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-004-62680940004623 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59) 3 tray2016-10-260000-00-00NoNoCurrent