Cetirizine Hydrochloride

Product NDC
68071-2482
11-digit product format
680712482
Labeler code
68071
Product ID
68071-2482_c7d1829b-2cf2-aeed-e053-2a95a90ae11a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2482-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET301
68071-2482-7Cetirizine Hydrochloride7 in 1 BOTTLETABLET71
68071-2482-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2482CETIRIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 3 package rows20210724_c7d1829b-2cf3-aeed-e053-2a95a90ae11a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc7d1829b-2cf3-aeed-e053-2a95a90ae11a1
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc7d1829b-2cf3-aeed-e053-2a95a90ae11a1
1014678cetirizine HCl 10 MG Oral TabletSYc7d1829b-2cf3-aeed-e053-2a95a90ae11a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2482-36807124820330 TABLET in 1 BOTTLE (68071-2482-3) 30 tablet2021-07-230000-00-00NoNoCurrent
68071-2482-7680712482077 TABLET in 1 BOTTLE (68071-2482-7) 7 tablet2021-07-230000-00-00NoNoCurrent
68071-2482-96807124820990 TABLET in 1 BOTTLE (68071-2482-9) 90 tablet2021-07-230000-00-00NoNoCurrent