fexofenadine hydrochloride

Generic: fexofenadine hcl

Labeler: northwind health company, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hcl
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-231
Product ID 51655-231_48d2c7f6-8550-1b9c-e063-6394a90ada4e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Marketing Start 2022-11-16
Marketing End 2026-10-28

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 51655231
Hyphenated Format 51655-231

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 hydrochloride (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
  • 90 TABLET in 1 BOTTLE, PLASTIC (51655-231-26)
  • 30 TABLET in 1 BOTTLE, PLASTIC (51655-231-52)
source: ndc

Packages (2)

51655-231-26 90 TABLET in 1 BOTTLE, PLASTIC (51655-231-26) 51655-231-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-231-52)

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": "48d2c7f6-8550-1b9c-e063-6394a90ada4e", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["f2b6c157-1af1-8d43-e053-2995a90aaf1a"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (51655-231-26)", "package_ndc": "51655-231-26", "marketing_end_date": "20261028", "marketing_start_date": "20221208"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (51655-231-52)", "package_ndc": "51655-231-52", "marketing_end_date": "20261028", "marketing_start_date": "20221116"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "51655-231_48d2c7f6-8550-1b9c-e063-6394a90ada4e", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51655-231", "generic_name": "Fexofenadine HCl", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204507", "marketing_category": "ANDA", "marketing_end_date": "20261028", "marketing_start_date": "20221116"}