FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
68788-8435
11-digit product format
687888435
Labeler code
68788
Product ID
68788-8435_8efeffe6-f264-4a44-a348-63a33f9c6d25
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078343
Marketing category
ANDA
Marketing start
2023-04-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride
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
68788-8435-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
68788-8435-6Cetirizine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
68788-8435-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8435-3EA - Each68788-8435c76e5820-b930-4d9c-931d-6bb8c8cb3d2212023-06-06
68788-8435-6EA - Each68788-8435dea7f32e-645e-4130-a0f3-dad84c15f29b12023-06-06
68788-8435-9EA - Each68788-8435101eff2b-afc7-47b5-8da8-6456f98ff71212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8435CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250227_14a885e5-5e75-4a18-b5bc-6aaa748712db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN14a885e5-5e75-4a18-b5bc-6aaa748712db4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD14a885e5-5e75-4a18-b5bc-6aaa748712db4
1014678cetirizine HCl 10 MG Oral TabletSY14a885e5-5e75-4a18-b5bc-6aaa748712db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8435-36878884350330 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3) 2023-04-27NoNoHistorical
68788-8435-66878884350660 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6) 2023-04-27NoNoHistorical
68788-8435-96878884350990 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9) 2023-04-27NoNoHistorical