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, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-921
Product ID 63187-921_9d96cb6a-14e9-4dcb-84e4-63d98a716070
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2015-09-16

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 63187921
Hyphenated Format 63187-921

Supplemental Identifiers

RxCUI
997420
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 ANDA204507 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90)
source: ndc

Packages (4)

63187-921-20 20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20) 63187-921-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30) 63187-921-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60) 63187-921-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90)

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": "9d96cb6a-14e9-4dcb-84e4-63d98a716070", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["3b147968-c6a8-4725-89b6-2eb443900e8f"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20)", "package_ndc": "63187-921-20", "marketing_start_date": "20171002"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30)", "package_ndc": "63187-921-30", "marketing_start_date": "20171002"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60)", "package_ndc": "63187-921-60", "marketing_start_date": "20171002"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90)", "package_ndc": "63187-921-90", "marketing_start_date": "20171002"}], "brand_name": "Fexofenadine HCl", "product_id": "63187-921_9d96cb6a-14e9-4dcb-84e4-63d98a716070", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63187-921", "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": "ANDA204507", "marketing_category": "ANDA", "marketing_start_date": "20150916", "listing_expiration_date": "20261231"}