fexofenadine hydrochloride and pseudoephedrine hydrochloride (0536-1431)

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride and pseudoephedrine hydrochloride

Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride

Labeler rugby laboratories

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

fexofenadine hydrochloride 60 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1431

Product ID 0536-1431_cc6df813-9175-4c0b-a8e4-afcaa3aa833f

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209116

Listing Expiration 2026-12-31

Marketing Start 2024-05-17

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 05361431

Hyphenated Format 0536-1431

Supplemental Identifiers

RxCUI

997406

UNII

2S068B75ZU 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 fexofenadine hydrochloride and pseudoephedrine hydrochloride (source: ndc)

Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA209116 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
120 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (0536-1431-34) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

0536-1431-07 3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 0536-1431-34 2 BLISTER PACK in 1 CARTON (0536-1431-34) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

fexofenadine hydrochloride (60 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "cc6df813-9175-4c0b-a8e4-afcaa3aa833f", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997406"], "spl_set_id": ["cc6df813-9175-4c0b-a8e4-afcaa3aa833f"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0536-1431-07)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1431-07", "marketing_start_date": "20240517"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0536-1431-34)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1431-34", "marketing_start_date": "20240517"}], "brand_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "0536-1431_cc6df813-9175-4c0b-a8e4-afcaa3aa833f", "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": "0536-1431", "generic_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA209116", "marketing_category": "ANDA", "marketing_start_date": "20240517", "listing_expiration_date": "20261231"}