fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-847
Product ID 45802-847_e43b561e-d68a-47af-be93-d710f0f77505
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212971
Listing Expiration 2026-12-31
Marketing Start 2022-01-07

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802847
Hyphenated Format 45802-847

Supplemental Identifiers

RxCUI
997420
UNII
2S068B75ZU

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 (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA212971 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

45802-847-78 1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

Fexofenadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e43b561e-d68a-47af-be93-d710f0f77505", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["e43b561e-d68a-47af-be93-d710f0f77505"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-847-78)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "45802-847-78", "marketing_start_date": "20220107"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "45802-847_e43b561e-d68a-47af-be93-d710f0f77505", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "45802-847", "generic_name": "fexofenadine hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA212971", "marketing_category": "ANDA", "marketing_start_date": "20220107", "listing_expiration_date": "20261231"}