fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: chain drug consortium, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler chain drug consortium, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Chain Drug Consortium, LLC

Identifiers & Regulatory

Product NDC 68016-995
Product ID 68016-995_9cb9fb1e-0d5d-763a-4950-4b0d53a5b9ee
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076502
Listing Expiration 2026-12-31
Marketing Start 2014-04-01

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 68016995
Hyphenated Format 68016-995

Supplemental Identifiers

RxCUI
997420
UNII
2S068B75ZU

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 ANDA076502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET in 1 BOTTLE
source: ndc

Packages (2)

68016-995-03 1 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLE 68016-995-45 1 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET 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": "9cb9fb1e-0d5d-763a-4950-4b0d53a5b9ee", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["d1d8d0ec-2bdd-fb07-a051-d6353e3c240c"], "manufacturer_name": ["Chain Drug Consortium, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-995-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "68016-995-03", "marketing_start_date": "20140401"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-995-45)  / 45 TABLET in 1 BOTTLE", "package_ndc": "68016-995-45", "marketing_start_date": "20140401"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "68016-995_9cb9fb1e-0d5d-763a-4950-4b0d53a5b9ee", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68016-995", "generic_name": "Fexofenadine hydrochloride", "labeler_name": "Chain Drug Consortium, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA076502", "marketing_category": "ANDA", "marketing_start_date": "20140401", "listing_expiration_date": "20261231"}