cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler innovus pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-190
Product ID 57483-190_89db2c96-62f6-4e75-8f0d-321b44094c60
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2026-12-31
Marketing Start 2025-04-28

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 57483190
Hyphenated Format 57483-190

Supplemental Identifiers

RxCUI
1014678
UPC
0357483002480
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
  • 365 TABLET in 1 BOTTLE (57483-190-14)
source: ndc

Packages (1)

57483-190-14 365 TABLET in 1 BOTTLE (57483-190-14)

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": "89db2c96-62f6-4e75-8f0d-321b44094c60", "openfda": {"upc": ["0357483002480"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["89db2c96-62f6-4e75-8f0d-321b44094c60"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 BOTTLE (57483-190-14)", "package_ndc": "57483-190-14", "marketing_start_date": "20250428"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "57483-190_89db2c96-62f6-4e75-8f0d-321b44094c60", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57483-190", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "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": "20250428", "listing_expiration_date": "20261231"}