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United States · US · US:69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc
Desloratadine
Orange BookUNIISPLATC R06AX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVirtus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR06AX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116954310710100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10)
- ndc116954310750500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50)
Annotations
UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078355
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FVF865388R",
"rxcui": "275635",
"inchikey": "JAUOIFJMECXRGI-UHFFFAOYSA-N",
"display_name": "DESLORATADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e4db30a5-48e5-4fe3-8793-30b6866f87c1": {
"match": "brand_token",
"title": "DESLORATADINE TABLET, FILM COATED [NATCO PHARMA USA LLC]",
"spl_version": "1",
"published_date": "2026-04-27"
}
},
"productid": "69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc",
"productndc": "69543-107",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078355",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 19, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DESLORATADINE",
"proprietary_name": "Desloratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078355",
"marketing_category": "ANDA",
"nonproprietary_name": "Desloratadine",
"start_marketing_date": "20150612",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AX27.
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