fexofenadine hydrochloride and pseudoephedrine hydrochloride (0363-2110)

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride and pseudoephedrine hydrochloride

Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride

Labeler walgreens

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

walgreens

Identifiers & Regulatory

Product NDC 0363-2110

Product ID 0363-2110_4f95c9cf-97d7-4cb3-a78a-5e3e91e86550

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA090818

Listing Expiration 2026-12-31

Marketing Start 2018-04-17

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 03632110

Hyphenated Format 0363-2110

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 ANDA090818 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
120 mg/1

source: ndc

Packaging

20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-20)
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-30)

source: ndc

Packages (2)

0363-2110-20 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-20) 0363-2110-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-30)

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": "4f95c9cf-97d7-4cb3-a78a-5e3e91e86550", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997406"], "spl_set_id": ["1ed05c85-7a1c-440d-a5d7-e229528cedcd"], "manufacturer_name": ["walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-20)", "package_ndc": "0363-2110-20", "marketing_start_date": "20180417"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-30)", "package_ndc": "0363-2110-30", "marketing_start_date": "20180417"}], "brand_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "0363-2110_4f95c9cf-97d7-4cb3-a78a-5e3e91e86550", "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": "0363-2110", "generic_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "walgreens", "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": "ANDA090818", "marketing_category": "ANDA", "marketing_start_date": "20180417", "listing_expiration_date": "20261231"}