Cetirizine Hydrochloride

Product NDC
68071-2570
11-digit product format
680712570
Labeler code
68071
Product ID
68071-2570_d0d86f58-9028-077e-e053-2995a90ad40b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
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
68071-2570-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
68071-2570-7Cetirizine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED73
68071-2570-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2570CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20230718_d0d89544-9f04-561c-e053-2995a90a35bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine HCl 10 MG Oral TabletSYd0d89544-9f04-561c-e053-2995a90a35bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2570-36807125700330 TABLET, FILM COATED in 1 BOTTLE (68071-2570-3) 2021-11-150000-00-00NoNoCurrent
68071-2570-7680712570077 TABLET, FILM COATED in 1 BOTTLE (68071-2570-7) 2021-11-150000-00-00NoNoCurrent
68071-2570-96807125700990 TABLET, FILM COATED in 1 BOTTLE (68071-2570-9) 2021-11-150000-00-00NoNoCurrent