fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

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

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler nuvicare llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
NUVICARE LLC

Identifiers & Regulatory

Product NDC 84324-008
Product ID 84324-008_16dc8e4f-54e3-4edd-87f8-30d072fabad1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210137
Listing Expiration 2026-12-31
Marketing Start 2024-07-17

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 84324008
Hyphenated Format 84324-008

Supplemental Identifiers

RxCUI
997420
UPC
0384324000060
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 ANDA210137 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 18 TABLET in 1 BOTTLE (84324-008-01)
source: ndc

Packages (1)

84324-008-01 18 TABLET in 1 BOTTLE (84324-008-01)

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (2)

FEXOFENADINE HYDROCHLORIDE ndc-match (0.9) FEXOFENADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16dc8e4f-54e3-4edd-87f8-30d072fabad1", "openfda": {"upc": ["0384324000060"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["bb47b839-3f49-4818-a62c-b6d2b09b15dc"], "manufacturer_name": ["NUVICARE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 TABLET in 1 BOTTLE (84324-008-01)", "package_ndc": "84324-008-01", "marketing_start_date": "20240717"}], "brand_name": "FEXOFENADINE HYDROCHLORIDE", "product_id": "84324-008_16dc8e4f-54e3-4edd-87f8-30d072fabad1", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "84324-008", "generic_name": "FEXOFENADINE HYDROCHLORIDE", "labeler_name": "NUVICARE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FEXOFENADINE HYDROCHLORIDE", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA210137", "marketing_category": "ANDA", "marketing_start_date": "20240717", "listing_expiration_date": "20261231"}