fexofenadine hcl

Generic: fexofenadine hcl

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-905
Product ID 71610-905_34917b34-89a7-2a13-e063-6394a90a9038
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

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 71610905
Hyphenated Format 71610-905

Supplemental Identifiers

RxCUI
997420
UNII
2S068B75ZU

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 (71610-905-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80)
source: ndc

Packages (4)

71610-905-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30) 71610-905-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) 71610-905-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) 71610-905-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80)

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": "34917b34-89a7-2a13-e063-6394a90a9038", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["34918a5a-c4c9-bc79-e063-6294a90acb85"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30)", "package_ndc": "71610-905-30", "marketing_start_date": "20250507"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53)", "package_ndc": "71610-905-53", "marketing_start_date": "20250507"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60)", "package_ndc": "71610-905-60", "marketing_start_date": "20250507"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80)", "package_ndc": "71610-905-80", "marketing_start_date": "20250507"}], "brand_name": "fexofenadine hcl", "product_id": "71610-905_34917b34-89a7-2a13-e063-6394a90a9038", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71610-905", "generic_name": "fexofenadine hcl", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20250310", "listing_expiration_date": "20261231"}