fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: spirit pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler spirit pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
SPIRIT PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 68210-2210
Product ID 68210-2210_292e71ee-f44d-0821-e063-6394a90a4187
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204507
Listing Expiration 2026-12-31
Marketing Start 2020-03-17

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 682102210
Hyphenated Format 68210-2210

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 PACKAGE (68210-2210-1)
source: ndc

Packages (1)

68210-2210-1 100 TABLET, FILM COATED in 1 PACKAGE (68210-2210-1)

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": "292e71ee-f44d-0821-e063-6394a90a4187", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["ae0f16f6-d07a-47e1-adb8-07803c6cfb13"], "manufacturer_name": ["SPIRIT PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 PACKAGE (68210-2210-1)", "package_ndc": "68210-2210-1", "marketing_start_date": "20200317"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "68210-2210_292e71ee-f44d-0821-e063-6394a90a4187", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68210-2210", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "SPIRIT PHARMACEUTICALS 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_start_date": "20200317", "listing_expiration_date": "20261231"}