cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler aurohealth llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-812
Product ID 58602-812_146cd9eb-d2c1-4424-9e37-350004f18507
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2015-08-05

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602812
Hyphenated Format 58602-812

Supplemental Identifiers

RxCUI
1014676 1014678
UPC
0358602444099
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetirizine hydrochloride (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (58602-812-04) / 10 TABLET in 1 BLISTER PACK (58602-812-83)
  • 1 BOTTLE in 1 CARTON (58602-812-09) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-812-17) / 45 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-812-23) / 120 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-812-39) / 365 TABLET in 1 BOTTLE
  • 1000 TABLET in 1 BOTTLE (58602-812-41)
  • 75 TABLET in 1 PACKAGE, COMBINATION (58602-812-99)
source: ndc

Packages (7)

58602-812-04 10 BLISTER PACK in 1 CARTON (58602-812-04) / 10 TABLET in 1 BLISTER PACK (58602-812-83) 58602-812-09 1 BOTTLE in 1 CARTON (58602-812-09) / 30 TABLET in 1 BOTTLE 58602-812-17 1 BOTTLE in 1 CARTON (58602-812-17) / 45 TABLET in 1 BOTTLE 58602-812-23 1 BOTTLE in 1 CARTON (58602-812-23) / 120 TABLET in 1 BOTTLE 58602-812-39 1 BOTTLE in 1 CARTON (58602-812-39) / 365 TABLET in 1 BOTTLE 58602-812-41 1000 TABLET in 1 BOTTLE (58602-812-41) 58602-812-99 75 TABLET in 1 PACKAGE, COMBINATION (58602-812-99)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "146cd9eb-d2c1-4424-9e37-350004f18507", "openfda": {"upc": ["0358602444099"], "unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (58602-812-04)  / 10 TABLET in 1 BLISTER PACK (58602-812-83)", "package_ndc": "58602-812-04", "marketing_start_date": "20150805"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-812-09)  / 30 TABLET in 1 BOTTLE", "package_ndc": "58602-812-09", "marketing_start_date": "20150805"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-812-17)  / 45 TABLET in 1 BOTTLE", "package_ndc": "58602-812-17", "marketing_start_date": "20150805"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-812-23)  / 120 TABLET in 1 BOTTLE", "package_ndc": "58602-812-23", "marketing_start_date": "20150805"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-812-39)  / 365 TABLET in 1 BOTTLE", "package_ndc": "58602-812-39", "marketing_start_date": "20150805"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (58602-812-41)", "package_ndc": "58602-812-41", "marketing_start_date": "20150805"}, {"sample": false, "description": "75 TABLET in 1 PACKAGE, COMBINATION (58602-812-99)", "package_ndc": "58602-812-99", "marketing_start_date": "20150805"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "58602-812_146cd9eb-d2c1-4424-9e37-350004f18507", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-812", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20150805", "listing_expiration_date": "20261231"}