fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: granules india limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler granules india limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Granules India Limited

Identifiers & Regulatory

Product NDC 62207-891
Product ID 62207-891_44f30c29-5caf-7d3c-e063-6394a90a7d36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2023-11-07

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 62207891
Hyphenated Format 62207-891

Supplemental Identifiers

RxCUI
997420 997501
UPC
0362207891516 0362207889605 0362207891585 0362207889513
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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49)
  • 1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE
  • 7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

62207-891-49 1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49) 62207-891-51 1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE 62207-891-58 7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "44f30c29-5caf-7d3c-e063-6394a90a7d36", "openfda": {"upc": ["0362207891516", "0362207889605", "0362207891585", "0362207889513"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["e0537b71-fdee-4122-9c09-868ce7352080"], "manufacturer_name": ["Granules India Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49)", "package_ndc": "62207-891-49", "marketing_start_date": "20231107"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62207-891-51)  / 10 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "62207-891-51", "marketing_start_date": "20231107"}, {"sample": false, "description": "7 BLISTER PACK in 1 CARTON (62207-891-58)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "62207-891-58", "marketing_start_date": "20231107"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "62207-891_44f30c29-5caf-7d3c-e063-6394a90a7d36", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62207-891", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "Granules India Limited", "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": "20231107", "listing_expiration_date": "20261231"}