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 71610-893
Product ID 71610-893_31e71ef2-159c-8273-e063-6294a90aaa08
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 71610893
Hyphenated Format 71610-893

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
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-893-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-893-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70)
source: ndc

Packages (3)

71610-893-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-893-53) 71610-893-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-893-60) 71610-893-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70)

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": "31e71ef2-159c-8273-e063-6294a90aaa08", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["31e71ee7-c4b5-6c1c-e063-6294a90a1513"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-893-53)", "package_ndc": "71610-893-53", "marketing_start_date": "20250402"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-893-60)", "package_ndc": "71610-893-60", "marketing_start_date": "20250402"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70)", "package_ndc": "71610-893-70", "marketing_start_date": "20250402"}], "brand_name": "fexofenadine hcl", "product_id": "71610-893_31e71ef2-159c-8273-e063-6294a90aaa08", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71610-893", "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": "20240820", "listing_expiration_date": "20261231"}