fexofenadine hcl

Generic: fexofenadine hcl

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-196
Product ID 72789-196_40ac042c-0bf7-c7f4-e063-6294a90a4094
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204097
Listing Expiration 2026-12-31
Marketing Start 2019-02-18

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 72789196
Hyphenated Format 72789-196

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 hcl (source: ndc)
Generic Name fexofenadine hcl (source: ndc)
Application Number ANDA204097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE, PLASTIC (72789-196-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-196-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-196-90)
source: ndc

Packages (3)

72789-196-10 10 TABLET in 1 BOTTLE, PLASTIC (72789-196-10) 72789-196-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-196-30) 72789-196-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-196-90)

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

Fexofenadine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40ac042c-0bf7-c7f4-e063-6294a90a4094", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["07460764-43fa-49fd-ae77-d4571cb9f944"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (72789-196-10)", "package_ndc": "72789-196-10", "marketing_start_date": "20230314"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-196-30)", "package_ndc": "72789-196-30", "marketing_start_date": "20220915"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-196-90)", "package_ndc": "72789-196-90", "marketing_start_date": "20210706"}], "brand_name": "Fexofenadine HCL", "product_id": "72789-196_40ac042c-0bf7-c7f4-e063-6294a90a4094", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72789-196", "generic_name": "Fexofenadine HCL", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCL", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204097", "marketing_category": "ANDA", "marketing_start_date": "20190218", "listing_expiration_date": "20261231"}