fexofenadine hydrochloride

Generic: fexofenadine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hcl
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7050
Product ID 0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Marketing Start 2019-11-29
Marketing End 2026-10-28

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 09047050
Hyphenated Format 0904-7050

Supplemental Identifiers

RxCUI
997420
UPC
0309047050406
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 hcl (source: ndc)
Application Number ANDA204507 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40)
  • 100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)
source: ndc

Packages (2)

0904-7050-40 500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40) 0904-7050-60 100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)

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": "33be2075-3e84-4738-af91-6f2f971cc0b4", "openfda": {"upc": ["0309047050406"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["c34cda59-8a63-48ab-a19d-c06a1878f5da"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40)", "package_ndc": "0904-7050-40", "marketing_end_date": "20261028", "marketing_start_date": "20191129"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)", "package_ndc": "0904-7050-60", "marketing_end_date": "20261028", "marketing_start_date": "20191129"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "0904-7050_33be2075-3e84-4738-af91-6f2f971cc0b4", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7050", "generic_name": "Fexofenadine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204507", "marketing_category": "ANDA", "marketing_end_date": "20261028", "marketing_start_date": "20191129"}