fexofenadine hcl

Generic: fexofenadine hcl

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

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-531
Product ID 71205-531_db8ffe8f-d7f1-48f5-8ed2-9acca4e27884
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204097
Listing Expiration 2026-12-31
Marketing Start 2016-08-19

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 71205531
Hyphenated Format 71205-531

Supplemental Identifiers

RxCUI
997420
UPC
0371205531607
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 ANDA204097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71205-531-10)
  • 15 TABLET in 1 BOTTLE (71205-531-15)
  • 20 TABLET in 1 BOTTLE (71205-531-20)
  • 30 TABLET in 1 BOTTLE (71205-531-30)
  • 60 TABLET in 1 BOTTLE (71205-531-60)
  • 90 TABLET in 1 BOTTLE (71205-531-90)
source: ndc

Packages (6)

71205-531-10 10 TABLET in 1 BOTTLE (71205-531-10) 71205-531-15 15 TABLET in 1 BOTTLE (71205-531-15) 71205-531-20 20 TABLET in 1 BOTTLE (71205-531-20) 71205-531-30 30 TABLET in 1 BOTTLE (71205-531-30) 71205-531-60 60 TABLET in 1 BOTTLE (71205-531-60) 71205-531-90 90 TABLET in 1 BOTTLE (71205-531-90)

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": "db8ffe8f-d7f1-48f5-8ed2-9acca4e27884", "openfda": {"upc": ["0371205531607"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["f9a7e836-6055-484f-a197-181220428574"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71205-531-10)", "package_ndc": "71205-531-10", "marketing_start_date": "20240311"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71205-531-15)", "package_ndc": "71205-531-15", "marketing_start_date": "20240311"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71205-531-20)", "package_ndc": "71205-531-20", "marketing_start_date": "20240311"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-531-30)", "package_ndc": "71205-531-30", "marketing_start_date": "20210203"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-531-60)", "package_ndc": "71205-531-60", "marketing_start_date": "20210203"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-531-90)", "package_ndc": "71205-531-90", "marketing_start_date": "20210203"}], "brand_name": "Fexofenadine HCL", "product_id": "71205-531_db8ffe8f-d7f1-48f5-8ed2-9acca4e27884", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71205-531", "generic_name": "Fexofenadine HCL", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCL", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204097", "marketing_category": "ANDA", "marketing_start_date": "20160819", "listing_expiration_date": "20261231"}