fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-739
Product ID 71205-739_4a9b4b7f-0441-44d3-86c7-2542ef4b119a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212971
Listing Expiration 2026-12-31
Marketing Start 2022-01-07

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 71205739
Hyphenated Format 71205-739

Supplemental Identifiers

RxCUI
997420
UPC
0371205739607
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 hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA212971 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-739-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-739-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-739-90)
source: ndc

Packages (3)

71205-739-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-739-30) 71205-739-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-739-60) 71205-739-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-739-90)

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

Fexofenadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a9b4b7f-0441-44d3-86c7-2542ef4b119a", "openfda": {"upc": ["0371205739607"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["4a9b4b7f-0441-44d3-86c7-2542ef4b119a"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-739-30)", "package_ndc": "71205-739-30", "marketing_start_date": "20221228"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-739-60)", "package_ndc": "71205-739-60", "marketing_start_date": "20221228"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-739-90)", "package_ndc": "71205-739-90", "marketing_start_date": "20221228"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "71205-739_4a9b4b7f-0441-44d3-86c7-2542ef4b119a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71205-739", "generic_name": "fexofenadine hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA212971", "marketing_category": "ANDA", "marketing_start_date": "20220107", "listing_expiration_date": "20261231"}