FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
69842-237
11-digit product format
698420237
Labeler code
69842
Product ID
69842-237_621f3d87-d69e-41e6-8ece-22099cb87c01
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2019-07-26
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 (Allergy)
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-237-01Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-01Cetirizine Hydrochloride (Allergy)14 in 1 BLISTER PACKTABLET147
69842-237-09Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET307
69842-237-09Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-17Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-17Cetirizine Hydrochloride (Allergy)45 in 1 BOTTLETABLET457
69842-237-19Cetirizine Hydrochloride (Allergy)90 in 1 BOTTLETABLET907
69842-237-19Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-23Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-23Cetirizine Hydrochloride (Allergy)120 in 1 BOTTLETABLET1207
69842-237-39Cetirizine Hydrochloride (Allergy)365 in 1 BOTTLETABLET3657
69842-237-45Cetirizine Hydrochloride (Allergy)2 in 1 CARTONTABLET27
69842-237-45Cetirizine Hydrochloride (Allergy)120 in 1 BOTTLETABLET1207
69842-237-54Cetirizine Hydrochloride (Allergy)70 in 1 BOTTLETABLET707
69842-237-54Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-57Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-57Cetirizine Hydrochloride (Allergy)5 in 1 BLISTER PACKTABLET57
69842-237-60Cetirizine Hydrochloride (Allergy)5 in 1 BLISTER PACKTABLET57
69842-237-60Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-91Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET17
69842-237-91Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-237-23EA - Each69842-23720e362ed-3e26-4488-b84c-45d04fbb197212021-05-05
69842-237-39EA - Each69842-2377a0e01d7-11b4-4f44-ba93-ec3ced105d1c12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-237CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [CVS PHARMACY, INC.]7Current NDC, Legacy NDC, 21 package rows20240331_e340cd4b-5413-42c6-a956-eb15c3807aeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe340cd4b-5413-42c6-a956-eb15c3807aeb7
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe340cd4b-5413-42c6-a956-eb15c3807aeb7
1014678cetirizine HCl 10 MG Oral TabletSYe340cd4b-5413-42c6-a956-eb15c3807aeb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-237-01698420237011 BLISTER PACK in 1 CARTON (69842-237-01) / 14 TABLET in 1 BLISTER PACK1 blister pack2019-07-260000-00-00NoNoCurrent
69842-237-09698420237091 BOTTLE in 1 CARTON (69842-237-09) / 30 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
69842-237-17698420237171 BOTTLE in 1 CARTON (69842-237-17) / 45 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
69842-237-19698420237191 BOTTLE in 1 CARTON (69842-237-19) / 90 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
69842-237-23698420237231 BOTTLE in 1 CARTON (69842-237-23) / 120 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
69842-237-3969842023739365 TABLET in 1 BOTTLE (69842-237-39) 365 tablet2019-07-260000-00-00NoNoCurrent
69842-237-45698420237452 BOTTLE in 1 CARTON (69842-237-45) / 120 TABLET in 1 BOTTLE2 bottle2019-07-260000-00-00NoNoCurrent
69842-237-54698420237541 BOTTLE in 1 CARTON (69842-237-54) > 70 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent
69842-237-57698420237571 BLISTER PACK in 1 CARTON (69842-237-57) > 5 TABLET in 1 BLISTER PACK1 blister pack2019-07-260000-00-00NoNoCurrent
69842-237-60698420237601 BLISTER PACK in 1 CARTON (69842-237-60) > 5 TABLET in 1 BLISTER PACK1 blister pack2019-07-260000-00-00NoNoCurrent
69842-237-91698420237911 BOTTLE in 1 CARTON (69842-237-91) > 30 TABLET in 1 BOTTLE1 bottle2019-07-260000-00-00NoNoCurrent