fexofenadine hcl

Generic: fexofenadine hcl

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fexofenadine hydrochloride 60 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-201
Product ID 50228-201_2a0b48b8-5955-9ab7-e063-6394a90a6b24
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2014-12-26

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 50228201
Hyphenated Format 50228-201

Supplemental Identifiers

RxCUI
997420 997501
UPC
0350228202015 0350228201032 0350228202022 0350228201025 0350228201018 0350228202046 0350228201049 0350228202039
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
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04)
source: ndc

Packages (4)

50228-201-01 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01) 50228-201-02 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02) 50228-201-03 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03) 50228-201-04 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04)

Ingredients (1)

fexofenadine hydrochloride (60 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": "2a0b48b8-5955-9ab7-e063-6394a90a6b24", "openfda": {"upc": ["0350228202015", "0350228201032", "0350228202022", "0350228201025", "0350228201018", "0350228202046", "0350228201049", "0350228202039"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["b7e9477d-33d9-4463-b8a6-69af5f71ce35"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01)", "package_ndc": "50228-201-01", "marketing_start_date": "20141226"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02)", "package_ndc": "50228-201-02", "marketing_start_date": "20141226"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03)", "package_ndc": "50228-201-03", "marketing_start_date": "20141226"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04)", "package_ndc": "50228-201-04", "marketing_start_date": "20141226"}], "brand_name": "fexofenadine hcl", "product_id": "50228-201_2a0b48b8-5955-9ab7-e063-6394a90a6b24", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50228-201", "generic_name": "fexofenadine hcl", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "fexofenadine hcl", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA204507", "marketing_category": "ANDA", "marketing_start_date": "20141226", "listing_expiration_date": "20261231"}