fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: sam's west inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler sam's west inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Sam's West Inc.

Identifiers & Regulatory

Product NDC 68196-107
Product ID 68196-107_573483c1-14c7-7ff1-a6ee-2d01a988333a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076502
Listing Expiration 2026-12-31
Marketing Start 2017-05-09

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 68196107
Hyphenated Format 68196-107

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 (68196-107-15) / 150 TABLET in 1 BOTTLE
  • 150 TABLET in 1 BOTTLE (68196-107-50)
source: ndc

Packages (2)

68196-107-15 1 BOTTLE in 1 CARTON (68196-107-15) / 150 TABLET in 1 BOTTLE 68196-107-50 150 TABLET in 1 BOTTLE (68196-107-50)

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": "573483c1-14c7-7ff1-a6ee-2d01a988333a", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["1c1f43c4-7128-37c4-83fe-7eefac3fd477"], "manufacturer_name": ["Sam's West Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68196-107-15)  / 150 TABLET in 1 BOTTLE", "package_ndc": "68196-107-15", "marketing_start_date": "20170509"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (68196-107-50)", "package_ndc": "68196-107-50", "marketing_start_date": "20230401"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "68196-107_573483c1-14c7-7ff1-a6ee-2d01a988333a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-107", "generic_name": "Fexofenadine hydrochloride", "labeler_name": "Sam's West Inc.", "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": "20170509", "listing_expiration_date": "20261231"}