FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
58602-838
11-digit product format
586020838
Labeler code
58602
Product ID
58602-838_ef1f5185-9a05-4092-9bdc-954102616ccb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA213557
Marketing category
ANDA
Marketing start
2020-09-11
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
Rxcui1011482

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-838-14Cetirizine Hydrochloride11 in 1 CARTONTABLET, ORALLY DISINTEGRATING115
58602-838-19Cetirizine Hydrochloride20 in 1 CARTONTABLET, ORALLY DISINTEGRATING205
58602-838-74Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING65
58602-838-75Cetirizine Hydrochloride2 in 1 CARTONTABLET, ORALLY DISINTEGRATING25
58602-838-76Cetirizine Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-838CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC]5Current NDC, Legacy NDC, 5 package rows20250130_17e93c22-1ff7-4af9-bd5a-448836aec65f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011482cetirizine HCl 10 MG Disintegrating Oral TabletPSN17e93c22-1ff7-4af9-bd5a-448836aec65f5
1011482cetirizine hydrochloride 10 MG Disintegrating Oral TabletSCD17e93c22-1ff7-4af9-bd5a-448836aec65f5
1011482cetirizine HCl 10 MG Disintegrating Oral TabletSY17e93c22-1ff7-4af9-bd5a-448836aec65f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-838-145860208381411 BLISTER PACK in 1 CARTON (58602-838-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) 11 blister pack2020-09-110000-00-00NoNoCurrent
58602-838-195860208381920 BLISTER PACK in 1 CARTON (58602-838-19) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) 20 blister pack2025-01-28NoNoCurrent
58602-838-74586020838746 in 1 BLISTER PACKHistorical
58602-838-75586020838752 BLISTER PACK in 1 CARTON (58602-838-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) 2 blister pack2020-09-110000-00-00NoNoCurrent
58602-838-76586020838764 BLISTER PACK in 1 CARTON (58602-838-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) 4 blister pack2020-09-110000-00-00NoNoCurrent