Cetirizine HCl

Product NDC
72657-131
11-digit product format
726570131
Labeler code
72657
Product ID
72657-131_9b19f466-3796-44b8-a637-092926c275f1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
KIT
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA078427
Marketing category
ANDA
Marketing start
2024-05-13
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014676, 1014678

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
72657-131-89Cetirizine HCl1 in 1 PACKAGEKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-131CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA]5Current NDC, 1 package rows20250423_04b08c52-5390-4cdb-a9e7-fca81fffdc73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014676cetirizine HCl 5 MG Oral TabletPSN04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014678cetirizine hydrochloride 10 MG Oral TabletSCD04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014676cetirizine hydrochloride 5 MG Oral TabletSCD04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014678cetirizine HCl 10 MG Oral TabletSY04b08c52-5390-4cdb-a9e7-fca81fffdc735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-131-89726570131891 KIT in 1 PACKAGE (72657-131-89) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE1 kit2024-05-13NoNoCurrent