cetirizine hydrochloride and pseudoephedrine hydrochloride (45802-147)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride and pseudoephedrine hydrochloride

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride

Labeler padagis israel pharmaceuticals ltd

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 5 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-147

Product ID 45802-147_1e179f00-1e00-4199-bf78-bb00aa268c74

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210719

Listing Expiration 2026-12-31

Marketing Start 2020-03-31

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802147

Hyphenated Format 45802-147

Supplemental Identifiers

RxCUI

1014571

UNII

64O047KTOA 6V9V2RYJ8N

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 and pseudoephedrine hydrochloride (source: ndc)

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA210719 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
120 mg/1

source: ndc

Packaging

12 BLISTER PACK in 1 CARTON (45802-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
24 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

45802-147-53 12 BLISTER PACK in 1 CARTON (45802-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 45802-147-62 24 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

cetirizine hydrochloride (5 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Cetirizine hydrochloride and Pseudoephedrine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1e179f00-1e00-4199-bf78-bb00aa268c74", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["3260111b-35da-4f95-8081-51eae4b1ef45"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (45802-147-53)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "45802-147-53", "marketing_start_date": "20200331"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (45802-147-62)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "45802-147-62", "marketing_start_date": "20200331"}], "brand_name": "Cetirizine hydrochloride and Pseudoephedrine hydrochloride", "product_id": "45802-147_1e179f00-1e00-4199-bf78-bb00aa268c74", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "45802-147", "generic_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride and Pseudoephedrine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA210719", "marketing_category": "ANDA", "marketing_start_date": "20200331", "listing_expiration_date": "20261231"}