Cetirizine HCl

Product NDC
72657-129
11-digit product format
726570129
Labeler code
72657
Product ID
72657-129_9b19f466-3796-44b8-a637-092926c275f1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA078427
Marketing category
ANDA
Marketing start
2024-05-13
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 HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

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
72657-129-03Cetirizine HCl300 in 1 BOTTLETABLET3005
72657-129-03Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-04Cetirizine HCl400 in 1 BOTTLETABLET4005
72657-129-04Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-08Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-08Cetirizine HCl120 in 1 BOTTLETABLET1205
72657-129-14Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-14Cetirizine HCl140 in 1 BOTTLETABLET1405
72657-129-15Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-15Cetirizine HCl150 in 1 BOTTLETABLET1505
72657-129-18Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-18Cetirizine HCl180 in 1 BOTTLETABLET1805
72657-129-24Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-24Cetirizine HCl240 in 1 BOTTLETABLET2405
72657-129-30Cetirizine HCl30 in 1 BOTTLETABLET305
72657-129-30Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-35Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-35Cetirizine HCl365 in 1 BOTTLETABLET3655
72657-129-41Cetirizine HCl14 in 1 BOTTLETABLET145
72657-129-41Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-45Cetirizine HCl45 in 1 BOTTLETABLET455
72657-129-45Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-60Cetirizine HCl60 in 1 BOTTLETABLET605
72657-129-60Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-70Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-70Cetirizine HCl70 in 1 BOTTLETABLET705
72657-129-81Cetirizine HCl2 in 1 CARTONTABLET25
72657-129-81Cetirizine HCl60 in 1 BOTTLETABLET605
72657-129-82Cetirizine HCl70 in 1 BOTTLETABLET705
72657-129-82Cetirizine HCl2 in 1 CARTONTABLET25
72657-129-84Cetirizine HCl90 in 1 BOTTLETABLET905
72657-129-84Cetirizine HCl2 in 1 CARTONTABLET25
72657-129-86Cetirizine HCl2 in 1 CARTONTABLET25
72657-129-86Cetirizine HCl120 in 1 BOTTLETABLET1205
72657-129-90Cetirizine HCl1 in 1 CARTONTABLET15
72657-129-90Cetirizine HCl90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-129-35EA - Each72657-1295cb77074-5486-40f6-bc68-30534114631412026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-129CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA]5Current NDC, 36 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
72657-129-03726570129031 BOTTLE in 1 CARTON (72657-129-03) / 300 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-04726570129041 BOTTLE in 1 CARTON (72657-129-04) / 400 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-08726570129081 BOTTLE in 1 CARTON (72657-129-08) / 120 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-14726570129141 BOTTLE in 1 CARTON (72657-129-14) / 140 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-15726570129151 BOTTLE in 1 CARTON (72657-129-15) / 150 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-18726570129181 BOTTLE in 1 CARTON (72657-129-18) / 180 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-24726570129241 BOTTLE in 1 CARTON (72657-129-24) / 240 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-30726570129301 BOTTLE in 1 CARTON (72657-129-30) / 30 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-35726570129351 BOTTLE in 1 CARTON (72657-129-35) / 365 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-41726570129411 BOTTLE in 1 CARTON (72657-129-41) / 14 TABLET in 1 BOTTLE1 bottle2025-04-03NoNoCurrent
72657-129-45726570129451 BOTTLE in 1 CARTON (72657-129-45) / 45 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-60726570129601 BOTTLE in 1 CARTON (72657-129-60) / 60 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-70726570129701 BOTTLE in 1 CARTON (72657-129-70) / 70 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-129-81726570129812 BOTTLE in 1 CARTON (72657-129-81) / 60 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-129-82726570129822 BOTTLE in 1 CARTON (72657-129-82) / 70 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-129-84726570129842 BOTTLE in 1 CARTON (72657-129-84) / 90 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-129-86726570129862 BOTTLE in 1 CARTON (72657-129-86) / 120 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-129-90726570129901 BOTTLE in 1 CARTON (72657-129-90) / 90 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent