desloratadine

Generic: desloratadine

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name desloratadine
Generic Name desloratadine
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

desloratadine 5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-363
Product ID 69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078357
Listing Expiration 2026-12-31
Marketing Start 2023-11-28

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 69452363
Hyphenated Format 69452-363

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 ANDA078357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)
source: ndc

Packages (2)

69452-363-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20) 69452-363-30 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)

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": "63a77a01-b991-4f03-8f9f-4dd09c8302c4", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["FVF865388R"], "rxcui": ["349420"], "spl_set_id": ["4d094001-b85a-47b3-bc67-a46660384ece"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)", "package_ndc": "69452-363-20", "marketing_start_date": "20231128"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)", "package_ndc": "69452-363-30", "marketing_start_date": "20231128"}], "brand_name": "Desloratadine", "product_id": "69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69452-363", "generic_name": "Desloratadine", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Desloratadine", "active_ingredients": [{"name": "DESLORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA078357", "marketing_category": "ANDA", "marketing_start_date": "20231128", "listing_expiration_date": "20261231"}