rugby cetirizine hydrochloride and pseudoephedrine hydrochloride (0536-1279)

Drug Facts

Product Profile

Brand Name rugby cetirizine hydrochloride and pseudoephedrine hydrochloride

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride

Labeler rugby laboratories

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1279

Product ID 0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210719

Listing Expiration 2026-12-31

Marketing Start 2020-03-09

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 05361279

Hyphenated Format 0536-1279

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 rugby 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 (0536-1279-12) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
24 BLISTER PACK in 1 CARTON (0536-1279-35) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

0536-1279-12 12 BLISTER PACK in 1 CARTON (0536-1279-12) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 0536-1279-35 24 BLISTER PACK in 1 CARTON (0536-1279-35) / 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)

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "cf50d4ee-e05e-477a-b543-4ba232e53c80", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["5c6ac9a2-4f0a-4297-9b83-988d54598f75"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0536-1279-12)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1279-12", "marketing_start_date": "20200309"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (0536-1279-35)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1279-35", "marketing_start_date": "20200309"}], "brand_name": "Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80", "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": "0536-1279", "generic_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rugby 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": "20200309", "listing_expiration_date": "20261231"}