clarinex

Generic: desloratadine

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clarinex
Generic Name desloratadine
Labeler organon llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

desloratadine 5 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-119
Product ID 78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021165
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206119
Hyphenated Format 78206-119

Supplemental Identifiers

RxCUI
349420 352086
UPC
0378206188014 0378206119018
UNII
FVF865388R
NUI
N0000000190 N0000175587

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 clarinex (source: ndc)
Generic Name desloratadine (source: ndc)
Application Number NDA021165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)
source: ndc

Packages (1)

78206-119-01 100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)

Ingredients (1)

desloratadine (5 mg/1)

Linked Drug Pages (1)

Clarinex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6ec783d3-9308-4f6b-bfda-b41888b95102", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0378206188014", "0378206119018"], "unii": ["FVF865388R"], "rxcui": ["349420", "352086"], "spl_set_id": ["c671342e-69a2-4ca5-abc2-8166ed4240d4"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)", "package_ndc": "78206-119-01", "marketing_start_date": "20210601"}], "brand_name": "Clarinex", "product_id": "78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "78206-119", "generic_name": "Desloratadine", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clarinex", "active_ingredients": [{"name": "DESLORATADINE", "strength": "5 mg/1"}], "application_number": "NDA021165", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}