FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
68788-4072
11-digit product format
687884072
Labeler code
68788
Product ID
68788-4072_a462f9c0-45ef-49b1-b0d8-a02a75a4b731
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078336
Marketing category
ANDA
Marketing start
2026-01-27
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
68788-4072-3cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED11
68788-4072-3cetirizine hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
68788-4072-6cetirizine hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
68788-4072-9cetirizine hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4072-3EA - Each68788-4072217d1a45-9cc8-4e8a-8f6b-8577e510cb2112026-03-17
68788-4072-6EA - Each68788-40729d6400d4-e90d-45a4-92af-068b428fa61312026-03-17
68788-4072-9EA - Each68788-4072a211657b-e874-4407-b371-183960fee7fa12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNa462f9c0-45ef-49b1-b0d8-a02a75a4b7311
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa462f9c0-45ef-49b1-b0d8-a02a75a4b7311
1014678cetirizine HCl 10 MG Oral TabletSYa462f9c0-45ef-49b1-b0d8-a02a75a4b7311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4072-3687884072031 BOTTLE in 1 CARTON (68788-4072-3) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-01-27NoNoHistorical
68788-4072-66878840720660 TABLET, FILM COATED in 1 BOTTLE (68788-4072-6) 2026-01-27NoNoHistorical
68788-4072-96878840720990 TABLET, FILM COATED in 1 BOTTLE (68788-4072-9) 2026-01-27NoNoHistorical