fexofenadine hydrochloride and pseudoephedrine hydrochloride

Generic: fexofenadine hydrochloride and pseudoephedrine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride and pseudoephedrine hydrochloride
Generic Name fexofenadine hydrochloride and pseudoephedrine hydrochloride
Labeler aurohealth llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-807
Product ID 58602-807_0d3d02ae-9e54-4533-8b2c-300ee1f53b3a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209116
Listing Expiration 2026-12-31
Marketing Start 2017-10-30

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 58602807
Hyphenated Format 58602-807

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
  • 2 BLISTER PACK in 1 CARTON (58602-807-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58602-807-83) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (58602-807-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

58602-807-67 2 BLISTER PACK in 1 CARTON (58602-807-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 58602-807-83 1 BLISTER PACK in 1 CARTON (58602-807-83) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 58602-807-84 3 BLISTER PACK in 1 CARTON (58602-807-84) / 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": "0d3d02ae-9e54-4533-8b2c-300ee1f53b3a", "openfda": {"unii": ["2S068B75ZU", "6V9V2RYJ8N"], "rxcui": ["997406"], "spl_set_id": ["4726af84-83c1-456d-995c-f6a8d1583f8b"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-807-67)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-807-67", "marketing_start_date": "20171030"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-807-83)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-807-83", "marketing_start_date": "20171030"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-807-84)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-807-84", "marketing_start_date": "20171030"}], "brand_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "product_id": "58602-807_0d3d02ae-9e54-4533-8b2c-300ee1f53b3a", "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": "58602-807", "generic_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride", "labeler_name": "Aurohealth LLC", "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": "20171030", "listing_expiration_date": "20261231"}