desloratadine

Generic: desloratadine

Labeler: virtus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desloratadine
Generic Name desloratadine
Labeler virtus pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

desloratadine 5 mg/1

Manufacturer
Virtus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69543-107
Product ID 69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078355
Listing Expiration 2026-12-31
Marketing Start 2015-06-12

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 69543107
Hyphenated Format 69543-107

Supplemental Identifiers

RxCUI
349420
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 desloratadine (source: ndc)
Generic Name desloratadine (source: ndc)
Application Number ANDA078355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10)
  • 500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50)
source: ndc

Packages (2)

69543-107-10 100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10) 69543-107-50 500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50)

Ingredients (1)

desloratadine (5 mg/1)

Linked Drug Pages (1)

Desloratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7c658c72-2694-49dd-9950-0aed03e3d7dc", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["FVF865388R"], "rxcui": ["349420"], "spl_set_id": ["0fe374d0-c14b-4102-b568-eb79165fc7ef"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Virtus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10)", "package_ndc": "69543-107-10", "marketing_start_date": "20150612"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50)", "package_ndc": "69543-107-50", "marketing_start_date": "20150612"}], "brand_name": "Desloratadine", "product_id": "69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69543-107", "generic_name": "Desloratadine", "labeler_name": "Virtus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desloratadine", "active_ingredients": [{"name": "DESLORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA078355", "marketing_category": "ANDA", "marketing_start_date": "20150612", "listing_expiration_date": "20261231"}