Cetirizine Hydrochloride

Product NDC
51660-939
11-digit product format
516600939
Labeler code
51660
Product ID
51660-939_2a87ee90-da59-4e35-9cda-27759ba080d4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-939-01Cetirizine Hydrochloride100 in 1 BOTTLETABLET1008
51660-939-13Cetirizine Hydrochloride120 in 1 BOTTLETABLET1208
51660-939-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET308
51660-939-53Cetirizine Hydrochloride300 in 1 BOTTLETABLET3008
51660-939-54Cetirizine Hydrochloride14 in 1 BLISTER PACKTABLET148
51660-939-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-939CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]8Current NDC, Legacy NDC, 6 package rows20210525_161c4122-2c89-46e6-a6ae-db088087330d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNa7da81e1-8865-45c9-83c7-32fb8032ca2e15
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa7da81e1-8865-45c9-83c7-32fb8032ca2e15
1014678cetirizine HCl 10 MG Oral TabletSYa7da81e1-8865-45c9-83c7-32fb8032ca2e15
1014678cetirizine HCl 10 MG Oral TabletPSN161c4122-2c89-46e6-a6ae-db088087330d8
1014678cetirizine hydrochloride 10 MG Oral TabletSCD161c4122-2c89-46e6-a6ae-db088087330d8
1014678cetirizine HCl 10 MG Oral TabletSY161c4122-2c89-46e6-a6ae-db088087330d8
1014678cetirizine HCl 10 MG Oral TabletPSNd14feb90-3ca2-4d5b-825c-25fc2252ca385
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd14feb90-3ca2-4d5b-825c-25fc2252ca385
1014678cetirizine HCl 10 MG Oral TabletSYd14feb90-3ca2-4d5b-825c-25fc2252ca385
1014678cetirizine HCl 10 MG Oral TabletPSN9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3
1014678cetirizine HCl 10 MG Oral TabletSY9ff21853-ff3d-4b0e-a4a6-342d0ef459ae3
1014678cetirizine HCl 10 MG Oral TabletPSNd0d8b376-9001-8776-e053-2a95a90ae6512
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd0d8b376-9001-8776-e053-2a95a90ae6512
1014678cetirizine HCl 10 MG Oral TabletSYd0d8b376-9001-8776-e053-2a95a90ae6512
1014678cetirizine HCl 10 MG Oral TabletPSN296e5977-0e8c-4147-a94d-374eb913ab511
1014678cetirizine HCl 10 MG Oral TabletPSN357523b6-618b-4bff-a80d-c62e72a0804e1
1014678cetirizine HCl 10 MG Oral TabletPSN1cfedef0-7cd3-8cd9-e063-6294a90a525d1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD357523b6-618b-4bff-a80d-c62e72a0804e1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD296e5977-0e8c-4147-a94d-374eb913ab511
1014678cetirizine hydrochloride 10 MG Oral TabletSCD1cfedef0-7cd3-8cd9-e063-6294a90a525d1
1014678cetirizine HCl 10 MG Oral TabletSY357523b6-618b-4bff-a80d-c62e72a0804e1
1014678cetirizine HCl 10 MG Oral TabletSY296e5977-0e8c-4147-a94d-374eb913ab511
1014678cetirizine HCl 10 MG Oral TabletSY1cfedef0-7cd3-8cd9-e063-6294a90a525d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-939-0151660093901100 TABLET in 1 BOTTLE (51660-939-01) 100 tablet2007-12-270000-00-00NoNoCurrent
51660-939-04516600939045000 TABLET in 1 BAG (51660-939-04)5000 tablet28-NOV-24Current
51660-939-1351660093913120 TABLET in 1 BOTTLE (51660-939-13) 120 tablet2007-12-270000-00-00NoNoCurrent
51660-939-305166009393030 TABLET in 1 BOTTLE (51660-939-30) 30 tablet2007-12-270000-00-00NoNoCurrent
51660-939-5351660093953300 TABLET in 1 BOTTLE (51660-939-53) 300 tablet2007-12-270000-00-00NoNoCurrent
51660-939-545166009395414 TABLET in 1 BLISTER PACK (51660-939-54) 14 tablet2007-12-270000-00-00NoNoCurrent
51660-939-905166009399090 TABLET in 1 BOTTLE (51660-939-90) 90 tablet2007-12-270000-00-00NoNoCurrent