Cetirizine Hydrochloride

Product NDC
71141-133
11-digit product format
711410133
Labeler code
71141
Product ID
71141-133_4cf9e5b8-0be6-4a8b-9ee3-7e7272864279
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
LIDL US, LLC
Application
ANDA077498
Marketing category
ANDA
Marketing start
2017-09-01
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride
Listing expiration
2026-12-31

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
71141-133-32Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET141
71141-133-32Cetirizine Hydrochloride1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-133CETIRIZINE HYDROCHLORIDE TABLET [LIDL US, LLC]1Current NDC, Legacy NDC, 2 package rows20180110_a210d6b7-0829-4120-bb6d-fee0c2e57b26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNa210d6b7-0829-4120-bb6d-fee0c2e57b261
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa210d6b7-0829-4120-bb6d-fee0c2e57b261
1014678cetirizine HCl 10 MG Oral TabletSYa210d6b7-0829-4120-bb6d-fee0c2e57b261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71141-133-32711410133321 BLISTER PACK in 1 CARTON (71141-133-32) / 14 TABLET in 1 BLISTER PACK1 blister pack2017-09-010000-00-00NoNoCurrent