fexofenadine hcl

Generic: fexofenadine hcl

Labeler: bryant ranch prepack
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2165
Product ID 71335-2165_04a27808-de0a-4100-9aff-3168e4fd231e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2021-08-26

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 713352165
Hyphenated Format 71335-2165

Supplemental Identifiers

RxCUI
997501
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
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4)
  • 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6)
  • 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)
source: ndc

Packages (7)

71335-2165-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1) 71335-2165-2 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2) 71335-2165-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3) 71335-2165-4 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4) 71335-2165-5 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5) 71335-2165-6 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6) 71335-2165-7 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)

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": "04a27808-de0a-4100-9aff-3168e4fd231e", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997501"], "spl_set_id": ["c23ad304-a5de-454e-a135-4eb143af2381"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1)", "package_ndc": "71335-2165-1", "marketing_start_date": "20240906"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2)", "package_ndc": "71335-2165-2", "marketing_start_date": "20220825"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3)", "package_ndc": "71335-2165-3", "marketing_start_date": "20240906"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4)", "package_ndc": "71335-2165-4", "marketing_start_date": "20240906"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5)", "package_ndc": "71335-2165-5", "marketing_start_date": "20240906"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6)", "package_ndc": "71335-2165-6", "marketing_start_date": "20240906"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7)", "package_ndc": "71335-2165-7", "marketing_start_date": "20221108"}], "brand_name": "fexofenadine hcl", "product_id": "71335-2165_04a27808-de0a-4100-9aff-3168e4fd231e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71335-2165", "generic_name": "fexofenadine hcl", "labeler_name": "Bryant Ranch Prepack", "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": "20210826", "listing_expiration_date": "20261231"}