CAREALL Cetirizine HCl

Product NDC
51824-076
11-digit product format
518240076
Labeler code
51824
Product ID
51824-076_44eb4b3e-e1e7-e47f-e063-6394a90a9b17
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
New World Imports
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-03-02
Marketing end
2026-07-01
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CAREALL Cetirizine HCl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

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
51824-076-01CAREALL Cetirizine HCl30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-076-01EA - Each51824-07640474a00-2c48-4cfe-b5a6-f125fcceff0a12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-076CAREALL CETIRIZINE HCL (CETIRIZINE) TABLET [NEW WORLD IMPORTS]5Current NDC, Legacy NDC, 1 package rows20241009_0542dfb2-6ef3-4242-b8fc-9e889757cbd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN0542dfb2-6ef3-4242-b8fc-9e889757cbd76
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0542dfb2-6ef3-4242-b8fc-9e889757cbd76
1014678cetirizine HCl 10 MG Oral TabletSY0542dfb2-6ef3-4242-b8fc-9e889757cbd76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-076-015182400760130 TABLET in 1 BOTTLE (51824-076-01) 30 tablet2020-03-022026-07-01NoNoCurrent