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United States · US · US:69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1
Desloratadine
Orange BookUNIISPLATC R06AX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNatco Pharma USA LLC
CountryUS (United States)
ATC codeR06AX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116933919401100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01)
- ndc116933919405500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05)
Annotations
UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078351
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": "69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1",
"productndc": "69339-194",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078351",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 10, 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": "ANDA078351",
"marketing_category": "ANDA",
"nonproprietary_name": "Desloratadine",
"start_marketing_date": "20260401",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AX27.
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