fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler amerisource bergen
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-779
Product ID 46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091567
Listing Expiration 2026-12-31
Marketing Start 2024-05-14

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 46122779
Hyphenated Format 46122-779

Supplemental Identifiers

RxCUI
997420
UPC
0346122779661
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 ANDA091567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

46122-779-58 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK 46122-779-61 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE 46122-779-66 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "76ea7e25-e968-4c78-9eca-ac960ad55985", "openfda": {"upc": ["0346122779661"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["2a578643-adc1-44ca-83f2-9d48527bd3a4"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (46122-779-58)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46122-779-58", "marketing_start_date": "20240514"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46122-779-61)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "46122-779-61", "marketing_start_date": "20240514"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46122-779-66)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "46122-779-66", "marketing_start_date": "20240514"}], "brand_name": "FEXOFENADINE HYDROCHLORIDE", "product_id": "46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "46122-779", "generic_name": "FEXOFENADINE HYDROCHLORIDE", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FEXOFENADINE HYDROCHLORIDE", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA091567", "marketing_category": "ANDA", "marketing_start_date": "20240514", "listing_expiration_date": "20261231"}