childrens cetirizine hydrochloride allergy

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens cetirizine hydrochloride allergy
Generic Name cetirizine hydrochloride
Labeler aurohealth llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-028
Product ID 58602-028_e407f522-6f4f-4049-a2df-23cb18c1eb1f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090750
Listing Expiration 2027-12-31
Marketing Start 2015-06-24

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 58602028
Hyphenated Format 58602-028

Supplemental Identifiers

UPC
0358602028244
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 childrens cetirizine hydrochloride allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-028-20) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-028-24) / 120 mL in 1 BOTTLE
  • 480 mL in 1 BOTTLE (58602-028-26)
source: ndc

Packages (3)

58602-028-20 1 BOTTLE in 1 CARTON (58602-028-20) / 240 mL in 1 BOTTLE 58602-028-24 1 BOTTLE in 1 CARTON (58602-028-24) / 120 mL in 1 BOTTLE 58602-028-26 480 mL in 1 BOTTLE (58602-028-26)

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Childrens Cetirizine Hydrochloride Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e407f522-6f4f-4049-a2df-23cb18c1eb1f", "openfda": {"upc": ["0358602028244"], "unii": ["64O047KTOA"], "spl_set_id": ["4de4f544-79cd-4a89-aafb-f2e2688b3c81"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-028-20)  / 240 mL in 1 BOTTLE", "package_ndc": "58602-028-20", "marketing_start_date": "20150624"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-028-24)  / 120 mL in 1 BOTTLE", "package_ndc": "58602-028-24", "marketing_start_date": "20150624"}, {"sample": false, "description": "480 mL in 1 BOTTLE (58602-028-26)", "package_ndc": "58602-028-26", "marketing_start_date": "20150624"}], "brand_name": "Childrens Cetirizine Hydrochloride Allergy", "product_id": "58602-028_e407f522-6f4f-4049-a2df-23cb18c1eb1f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-028", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cetirizine Hydrochloride Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090750", "marketing_category": "ANDA", "marketing_start_date": "20150624", "listing_expiration_date": "20271231"}