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
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Granules India Limited

Identifiers & Regulatory

Product NDC 62207-623
Product ID 62207-623_1d43d4d6-9021-eac7-e063-6294a90ad21a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2024-01-02

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 62207623
Hyphenated Format 62207-623

Supplemental Identifiers

RxCUI
997420
UPC
0362207623414 0362207623711
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
  • 24 TABLET in 1 CONTAINER (62207-623-41)
  • 225 TABLET in 1 CONTAINER (62207-623-45)
  • 90 TABLET in 1 CONTAINER (62207-623-57)
  • 7 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

62207-623-41 24 TABLET in 1 CONTAINER (62207-623-41) 62207-623-45 225 TABLET in 1 CONTAINER (62207-623-45) 62207-623-57 90 TABLET in 1 CONTAINER (62207-623-57) 62207-623-71 7 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET 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": "1d43d4d6-9021-eac7-e063-6294a90ad21a", "openfda": {"upc": ["0362207623414", "0362207623711"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["1d46555d-827b-b154-e063-6294a90ad3d5"], "manufacturer_name": ["Granules India Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 TABLET in 1 CONTAINER (62207-623-41)", "package_ndc": "62207-623-41", "marketing_start_date": "20240102"}, {"sample": false, "description": "225 TABLET in 1 CONTAINER (62207-623-45)", "package_ndc": "62207-623-45", "marketing_start_date": "20240102"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (62207-623-57)", "package_ndc": "62207-623-57", "marketing_start_date": "20240102"}, {"sample": false, "description": "7 BLISTER PACK in 1 CARTON (62207-623-71)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "62207-623-71", "marketing_start_date": "20240102"}], "brand_name": "Fexofenadine Hydrochloride", "product_id": "62207-623_1d43d4d6-9021-eac7-e063-6294a90ad21a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62207-623", "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": "20240102", "listing_expiration_date": "20261231"}