fexofenadine hcl

Generic: fexofenadine hcl

Labeler: camber consumer care
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler camber consumer care
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
Camber Consumer Care

Identifiers & Regulatory

Product NDC 69230-201
Product ID 69230-201_09845f21-f05e-34b2-e063-6394a90a7677
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2021-12-08

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 69230201
Hyphenated Format 69230-201

Supplemental Identifiers

RxCUI
997420 997501
UPC
0369230201015
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 (69230-201-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05)
source: ndc

Packages (2)

69230-201-01 100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01) 69230-201-05 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05)

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": "09845f21-f05e-34b2-e063-6394a90a7677", "openfda": {"upc": ["0369230201015"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["1bb1bea3-b17d-4326-b037-7468add0df80"], "manufacturer_name": ["Camber Consumer Care"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01)", "package_ndc": "69230-201-01", "marketing_start_date": "20211208"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05)", "package_ndc": "69230-201-05", "marketing_start_date": "20211208"}], "brand_name": "Fexofenadine HCl", "product_id": "69230-201_09845f21-f05e-34b2-e063-6394a90a7677", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69230-201", "generic_name": "Fexofenadine HCl", "labeler_name": "Camber Consumer Care", "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": "20211208", "listing_expiration_date": "20261231"}