crcle fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name crcle fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler innovus pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 60 mg/1

Manufacturer
Innovus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 57483-230
Product ID 57483-230_f672cd27-4516-4e54-8c4f-8bbdc22dfabd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2020-12-18

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 57483230
Hyphenated Format 57483-230

Supplemental Identifiers

RxCUI
997420 997501
UPC
0357483002466 0357483002459
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 crcle fexofenadine hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA211075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CONTAINER (57483-230-01)
source: ndc

Packages (1)

57483-230-01 100 TABLET in 1 CONTAINER (57483-230-01)

Ingredients (1)

fexofenadine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Crcle Fexofenadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f672cd27-4516-4e54-8c4f-8bbdc22dfabd", "openfda": {"upc": ["0357483002466", "0357483002459"], "unii": ["2S068B75ZU"], "rxcui": ["997420", "997501"], "spl_set_id": ["f7784610-7ca5-4489-b391-f2b3f3f6549b"], "manufacturer_name": ["Innovus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CONTAINER (57483-230-01)", "package_ndc": "57483-230-01", "marketing_start_date": "20230428"}], "brand_name": "Crcle Fexofenadine Hydrochloride", "product_id": "57483-230_f672cd27-4516-4e54-8c4f-8bbdc22dfabd", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57483-230", "generic_name": "Fexofenadine Hydrochloride", "labeler_name": "Innovus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Crcle Fexofenadine Hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211075", "marketing_category": "ANDA", "marketing_start_date": "20201218", "listing_expiration_date": "20261231"}