12hr allergy relief

Generic: fexofenadine hydrochloride

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name 12hr allergy relief
Generic Name fexofenadine hydrochloride
Labeler cardinal health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
CARDINAL HEALTH

Identifiers & Regulatory

Product NDC 70000-0586
Product ID 70000-0586_ccc271cc-6aa2-f753-e053-2995a90a1161
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2021-09-24

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 700000586
Hyphenated Format 70000-0586

Supplemental Identifiers

RxCUI
997501
UPC
0096295141474
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 12hr allergy relief (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA211075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70000-0586-1) / 12 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0586-1 1 BLISTER PACK in 1 CARTON (70000-0586-1) / 12 TABLET in 1 BLISTER PACK

Ingredients (1)

fexofenadine hydrochloride (60 mg/1)

Linked Drug Pages (1)

12HR Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ccc271cc-6aa2-f753-e053-2995a90a1161", "openfda": {"upc": ["0096295141474"], "unii": ["2S068B75ZU"], "rxcui": ["997501"], "spl_set_id": ["ea5d0e55-2191-4094-b082-24b317f95752"], "manufacturer_name": ["CARDINAL HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70000-0586-1)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0586-1", "marketing_start_date": "20210924"}], "brand_name": "12HR Allergy Relief", "product_id": "70000-0586_ccc271cc-6aa2-f753-e053-2995a90a1161", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0586", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "CARDINAL HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "12HR Allergy Relief", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211075", "marketing_category": "ANDA", "marketing_start_date": "20210924", "listing_expiration_date": "20261231"}