fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: safrel pharmaceuticals, llc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler safrel pharmaceuticals, llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Safrel Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71309-091
Product ID 71309-091_f7f18cee-5649-13c4-e053-6294a90ad4a8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2021-01-03

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 71309091
Hyphenated Format 71309-091

Supplemental Identifiers

RxCUI
997420
UPC
0371309091014
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 ANDA211075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71309-091-01)
source: ndc

Packages (1)

71309-091-01 100 TABLET in 1 BOTTLE (71309-091-01)

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": "f7f18cee-5649-13c4-e053-6294a90ad4a8", "openfda": {"upc": ["0371309091014"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["d6120f56-ab28-2696-e053-2995a90adf47"], "manufacturer_name": ["Safrel Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71309-091-01)", "package_ndc": "71309-091-01", "marketing_start_date": "20210131"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "71309-091_f7f18cee-5649-13c4-e053-6294a90ad4a8", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71309-091", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "Safrel Pharmaceuticals, LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA211075", "marketing_category": "ANDA", "marketing_start_date": "20210103", "listing_expiration_date": "20261231"}