fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-439
Product ID 68001-439_bd31cd71-9281-7667-e053-2995a90a4ac0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076502
Listing Expiration 2026-12-31
Marketing Start 2020-06-19

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 68001439
Hyphenated Format 68001-439

Supplemental Identifiers

RxCUI
997420 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 hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA076502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

68001-439-00 1 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (60 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": "bd31cd71-9281-7667-e053-2995a90a4ac0", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["a86aebd0-937e-5d73-e053-2995a90a656a"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-439-00)  / 100 TABLET in 1 BOTTLE", "package_ndc": "68001-439-00", "marketing_start_date": "20200619"}], "brand_name": "Fexofenadine hydrochloride", "product_id": "68001-439_bd31cd71-9281-7667-e053-2995a90a4ac0", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68001-439", "generic_name": "Fexofenadine hydrochloride", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA076502", "marketing_category": "ANDA", "marketing_start_date": "20200619", "listing_expiration_date": "20261231"}