fexofenadine hcl

Generic: fexofenadine hcl

Labeler: akron pharma inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler akron pharma inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
AKRON PHARMA INC

Identifiers & Regulatory

Product NDC 71399-8659
Product ID 71399-8659_48c50815-5149-7bba-e063-6294a90a714d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2027-12-31
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 713998659
Hyphenated Format 71399-8659

Supplemental Identifiers

RxCUI
997501
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5)
source: ndc

Packages (2)

71399-8659-1 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) 71399-8659-5 500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5)

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": "48c50815-5149-7bba-e063-6294a90a714d", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997501"], "spl_set_id": ["fe67f0f1-c6f1-424e-8226-19176de79945"], "manufacturer_name": ["AKRON PHARMA INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1)", "package_ndc": "71399-8659-1", "marketing_start_date": "20211101"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5)", "package_ndc": "71399-8659-5", "marketing_start_date": "20240202"}], "brand_name": "fexofenadine hcl", "product_id": "71399-8659_48c50815-5149-7bba-e063-6294a90a714d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71399-8659", "generic_name": "fexofenadine hcl", "labeler_name": "AKRON PHARMA 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": "20271231"}