FDA.reportPublic FDA data

Cetirizine

Product NDC
72162-2162
11-digit product format
721622162
Labeler code
72162
Product ID
72162-2162_d6e7e107-8d18-4bf5-a20f-90d80d5979cc
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-06-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine
Listing expiration
2027-12-31

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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2162-2Cetirizine300 in 1 BOTTLETABLET, FILM COATED300101
72162-2162-5Cetirizine500 in 1 BOTTLETABLET, FILM COATED500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2162-2EA - Each72162-21624aea600b-0bf8-4c24-a7e6-01db999fecf012024-03-12
72162-2162-5EA - Each72162-21621968578b-6147-43e1-aa44-d7d30f882e5812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2162CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240203_7e158fd6-268d-4ffc-a410-d054090d54c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN7e158fd6-268d-4ffc-a410-d054090d54c5101
1014678cetirizine hydrochloride 10 MG Oral TabletSCD7e158fd6-268d-4ffc-a410-d054090d54c5101
1014678cetirizine HCl 10 MG Oral TabletSY7e158fd6-268d-4ffc-a410-d054090d54c5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2162-272162216202300 TABLET, FILM COATED in 1 BOTTLE (72162-2162-2) 2018-07-03NoNoHistorical
72162-2162-572162216205500 TABLET, FILM COATED in 1 BOTTLE (72162-2162-5) 2018-07-03NoNoHistorical