fexofenadine hydrochloride

Generic: fexofenadine hydrochloride oral

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride oral
Labeler aurohealth llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 30 mg/5mL

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-426
Product ID 58602-426_a75ff860-f7e0-4e19-846b-fbe33e0e1dfd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213466
Listing Expiration 2026-12-31
Marketing Start 2023-05-23

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 58602426
Hyphenated Format 58602-426

Supplemental Identifiers

RxCUI
997491
UPC
0358602426200
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 oral (source: ndc)
Application Number ANDA213466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

58602-426-20 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE 58602-426-24 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

Fexofenadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a75ff860-f7e0-4e19-846b-fbe33e0e1dfd", "openfda": {"upc": ["0358602426200"], "unii": ["2S068B75ZU"], "rxcui": ["997491"], "spl_set_id": ["e8e35d7a-a86b-4d37-979b-f454978f070b"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-426-20)  / 240 mL in 1 BOTTLE", "package_ndc": "58602-426-20", "marketing_start_date": "20230523"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-426-24)  / 120 mL in 1 BOTTLE", "package_ndc": "58602-426-24", "marketing_start_date": "20230523"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "58602-426_a75ff860-f7e0-4e19-846b-fbe33e0e1dfd", "dosage_form": "SUSPENSION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-426", "generic_name": "Fexofenadine Hydrochloride Oral", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA213466", "marketing_category": "ANDA", "marketing_start_date": "20230523", "listing_expiration_date": "20261231"}