fexofenadine hcl

Generic: fexofenadine hcl

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

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7486
Product ID 0904-7486_b1390973-4ac1-40c9-b0e1-c7a4d04c0ee4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2024-08-20

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 09047486
Hyphenated Format 0904-7486

Supplemental Identifiers

RxCUI
997420 997501
UPC
0309047486021 0309047486601 0309047192045 0309047192601
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 hcl (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
  • 30 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40)
  • 100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60)
source: ndc

Packages (3)

0904-7486-02 30 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02) 0904-7486-40 500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40) 0904-7486-60 100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60)

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

fexofenadine hcl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1390973-4ac1-40c9-b0e1-c7a4d04c0ee4", "openfda": {"upc": ["0309047486021", "0309047486601", "0309047192045", "0309047192601"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["107f398c-f296-4190-8234-82556a039e65"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02)", "package_ndc": "0904-7486-02", "marketing_start_date": "20240820"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40)", "package_ndc": "0904-7486-40", "marketing_start_date": "20240820"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60)", "package_ndc": "0904-7486-60", "marketing_start_date": "20240820"}], "brand_name": "fexofenadine hcl", "product_id": "0904-7486_b1390973-4ac1-40c9-b0e1-c7a4d04c0ee4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7486", "generic_name": "fexofenadine hcl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "fexofenadine hcl", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204507", "marketing_category": "ANDA", "marketing_start_date": "20240820", "listing_expiration_date": "20261231"}