FDA.reportPublic FDA data

Cetirizine Hydrochloride Oral Solution

Product NDC
62135-057
11-digit product format
621350057
Labeler code
62135
Product ID
62135-057_06fce480-76eb-a204-e063-6394a90a3bbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA078876
Marketing category
ANDA
Marketing start
2012-05-11
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
Cetirizine Hydrochloride Oral Solution
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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-057-41Cetirizine Hydrochloride Oral Solution120 mL in 1 BOTTLESOLUTION1202
62135-057-47Cetirizine Hydrochloride Oral Solution473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-057-41ML - Milliliter62135-057e031eb44-cf69-4a5f-9839-dd66d3cff02c12022-09-12
62135-057-47ML - Milliliter62135-057513d5160-11f6-464b-941e-6fba2efce9ae12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-057CETIRIZINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 2 package rows20231006_41dc7107-a2d2-4519-ac6f-cbed9f07e9bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN41dc7107-a2d2-4519-ac6f-cbed9f07e9bf2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD41dc7107-a2d2-4519-ac6f-cbed9f07e9bf2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY41dc7107-a2d2-4519-ac6f-cbed9f07e9bf2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY41dc7107-a2d2-4519-ac6f-cbed9f07e9bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-057-4162135005741120 mL in 1 BOTTLE (62135-057-41) 120 ml2022-06-080000-00-00NoNoCurrent
62135-057-4762135005747473 mL in 1 BOTTLE (62135-057-47) 473 ml2022-06-080000-00-00NoNoCurrent